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Trial record 10 of 16 for:    IU/mL | BI 201335 OR faldaprevir

Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00774397
Recruitment Status : Completed
First Posted : October 17, 2008
Results First Posted : November 16, 2015
Last Update Posted : November 16, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: BI 201335 NA 240 mg QD / LI
Drug: PegIFN/RBV
Drug: BI 201335 NA 120mg QD / LI
Drug: BI 201335 NA 240 mg QD
Drug: BI 201335 NA 240 mg BID
Drug: Placebo
Enrollment 719
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV (Pegylated interferon α-2a (Pegasys®)/ Ribavirin (Copegus®)): PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Period Title: Overall Study
Started 71 69 143 146 143 76 71
Completed 57 56 113 129 97 54 41
Not Completed 14 13 30 17 46 22 30
Reason Not Completed
Adverse Event             1             3             16             8             8             3             16
Lack of Efficacy             11             4             5             3             27             15             9
Protocol Violation             0             1             3             1             2             1             0
Lost to Follow-up             0             1             1             1             0             1             0
Refused to continue trial medication             1             3             2             2             6             2             3
Not treated             0             0             0             0             1             0             1
Other than those stated above             1             1             3             2             2             0             1
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE Total
Hide Arm/Group Description

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Total of all reporting groups
Overall Number of Baseline Participants 71 69 143 146 142 76 70 717
Hide Baseline Analysis Population Description
Treated set: The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, whether randomised or not
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants 69 participants 143 participants 146 participants 142 participants 76 participants 70 participants 717 participants
45.6  (10.86) 46.3  (10.92) 44.7  (10.18) 46.3  (10.48) 48.7  (9.58) 49.6  (8.42) 50.1  (8.34) 47.14  (9.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 69 participants 143 participants 146 participants 142 participants 76 participants 70 participants 717 participants
Female
30
  42.3%
29
  42.0%
69
  48.3%
67
  45.9%
41
  28.9%
26
  34.2%
29
  41.4%
291
  40.6%
Male
41
  57.7%
40
  58.0%
74
  51.7%
79
  54.1%
101
  71.1%
50
  65.8%
41
  58.6%
426
  59.4%
1.Primary Outcome
Title Virological Response 4 Weeks After the End of Treatment With BI 201335 or Placebo
Hide Description

An achieved virological response is defined as the plasma Hepatitis C Virus RiboNucleic Acid (HCV RNA) level below the lower limit of detection (BLD).

This data was only collected for patients, who stopped trial participation at Week 24 and did not continue with PegIFN/RBV until Week 48.

The lower limit of quantification (BLQ) of this assay was 25 IU/mL and the lower limit of detection (BLD) was 10 IU/mL at the time of the protocol finalisation. During the course of the trial, the manufacturer defined BLD as '< 25 IU/mL, not detectable' and BLQ as '< 25 IU/mL, detectable'.

Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description

Per protocol set (PPS): PPS was subset of full analysis set,consisted of all patients without important protocol deviations .

FAS was composed of all randomised patients who took at least 1 dose of study medication.

For this outcome, only patients who were not on PegIFN/RBV treatment 4 weeks after stop of BI 201335 or Placebo were investigated.

Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 13 14 77 72 88 30 27
Measure Type: Number
Unit of Measure: percentage of patients
0.0 14.3 59.7 75.0 20.5 3.3 0.0
2.Primary Outcome
Title Sustained Virological Response 24 Weeks (SVR24) After Completion of All Therapy
Hide Description

Virological (VL) response was defined as the plasma HCV RNA level below the lower limit of detection.

The first VL measurement that occurred in the time window ≥ Day 155 (from End Of Treatment on) was selected for the determination of SVR24.

Therefore, patients with virological load BLD 24 weeks after completion of therapy, who had a rebound after this time point (outside the defined time window of 155 days after end of all treatments) were identified as SVR24 achieved.

Time Frame Day 155 after the end of all treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 71 69 141 142 142 76 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
56.3
(44.7 to 67.3)
72.5
(60.9 to 81.6)
72.3
(64.4 to 79.1)
83.8
(76.9 to 88.9)
28.2
(21.4 to 36.1)
40.8
(30.4 to 52.1)
31.4
(21.8 to 43.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo-TN, 120 mg QD / LI-TN
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0537
Comments P-value based on Fisher’s exact test (2-sided)
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo-TN, 240 mg QD / LI-TN
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0213
Comments P-value based on Fisher’s exact test (2-sided)
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo-TN, 240 mg QD-TN
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value based on Fisher’s exact test (2-sided)
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 240 mg QD / LI-TE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value based on Fisher’s exact test (2-sided)
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 240 mg QD-TE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value based on Fisher’s exact test (2-sided)
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 240 mg BID / LI-TE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value based on Fisher’s exact test (2-sided)
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Virological Response at Week 2
Hide Description Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 2 (< 25 IU/ml, detectable or undetectable)
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 71 69 141 142 142 76 70
Measure Type: Number
Unit of Measure: percentage of patients
1.4 69.6 66.7 82.4 27.5 34.2 47.1
4.Secondary Outcome
Title Virological Response at Week 4
Hide Description Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 4 (< 25 IU/ml, detectable or undetectable)
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 71 69 141 142 142 76 70
Measure Type: Number
Unit of Measure: percentage of patients
16.9 89.9 86.5 93.7 63.4 60.5 68.6
5.Secondary Outcome
Title Early Virological Response (EVR)
Hide Description Early Virological Response (EVR) is defined as ≥ 2 log 10 reduction in plasma HCV RNA level from baseline at Week 12
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 71 69 141 142 142 76 70
Measure Type: Number
Unit of Measure: percentage of patients
84.5 89.9 88.7 93.0 72.5 76.3 62.9
6.Secondary Outcome
Title Extended Rapid Virological Response (eRVR)
Hide Description Extended Rapid Virological Response (eRVR) is defined as plasma HCV RNA levels below the lower limit of quantification at Week 4 and below the lower limit of detection at Week 12
Time Frame Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 71 69 141 142 142 76 70
Measure Type: Number
Unit of Measure: percentage of patients
15.5 85.5 80.9 90.8 52.1 52.6 51.4
7.Secondary Outcome
Title Complete Early Virological Response (cEVR)
Hide Description Complete Early Virological Response (cEVR) is defined as plasma HCV RNA level below the lower limit of detection at Week 12
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 71 69 141 142 142 76 70
Measure Type: Number
Unit of Measure: percentage of patients
42.3 87.0 84.4 93.0 58.5 59.2 52.9
8.Secondary Outcome
Title End of Treatment Response at Week 24
Hide Description End of Treatment Response of BI 201335 or placebo (ETR BI 201335/placebo ) is defined as plasma HCV RNA level below the lower limit of detection at Week 24.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 71 69 141 142 142 76 70
Measure Type: Number
Unit of Measure: percentage of patients
73.2 82.6 77.3 88.0 58.5 52.6 52.9
9.Secondary Outcome
Title End of Treatment Response at End of All Therapy
Hide Description End of Treatment Response (ETR) is defined as plasma HCV RNA level below the lower limit of detection at end of all therapy, i.e. at Week 24 or Week 48
Time Frame Week 24 or Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 71 69 141 142 142 76 70
Measure Type: Number
Unit of Measure: percentage of patients
69.0 72.5 78.0 81.7 48.6 46.1 45.7
10.Secondary Outcome
Title Sustained Virological Response 12 Weeks (SVR12) After Completion of All Therapy
Hide Description Sustained Virological Response 12 Weeks (SVR12) after completion of all therapy is defined as plasma HCV RNA level below the lower limit of detection at 12 weeks after completion of all therapy, i.e. at Week 36 or 60
Time Frame Week 36 or Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 71 69 141 142 142 76 70
Measure Type: Number
Unit of Measure: percentage of patients
50.7 68.1 65.2 74.6 26.1 35.5 27.1
11.Secondary Outcome
Title Time to Reach a Plasma HCV RNA Level Below the Lower Limit of Detection
Hide Description Summary of time (i.e Median number of days) to reach a plasma HCV RNA level below limit of detection (BLD)
Time Frame On or after day 155 post end of all treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 71 69 141 142 142 76 70
Median (Full Range)
Unit of Measure: Days
113
(29 to 197)
29
(8 to 113)
29
(4 to 113)
29
(4 to 113)
56
(8 to 143)
56
(8 to 169)
29
(15 to 143)
12.Secondary Outcome
Title Time to Loss of Virological Response
Hide Description

Time to loss of virological response, defined as the last value below the lower limit of detection in a patient who subsequently had 2 consecutive plasma HCV RNA level measurements ≥100 IU/mL. Patients that did not achieve suppression of plasma HCV RNA levels below the lower limit of detection until Week 24 were defined as having a time to failure of zero.

Time is expressed in Median number of days.

Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 57 64 128 138 100 50 48
Median (95% Confidence Interval)
Unit of Measure: Number of days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
230 [2] 
(0 to NA)
370 [2] 
(0 to NA)
370 [2] 
(0 to NA)
[1]
More than 50% of all patients of the respective group have no loss of virological response at all, therefore no median can be calculated
[2]
NA stands for infinity
13.Secondary Outcome
Title Virological Rebound
Hide Description

Virological rebound is defined as increase of ≥ 1 log 10 in plasma HCV RNA level from a quantifiable nadir, or to ≥ 250 IU/mL after previous nadir < 25 IU/mL (detectable), or to ≥ 100 IU/mL after a previous viral load below the lower limit of detection.

Note that this is numerical rebound, not requiring confirmation with a re-measurement.

Time Frame Week 24 or Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 71 69 141 142 142 76 70
Measure Type: Number
Unit of Measure: percentage of patients
28.2 17.4 19.9 12.0 67.6 53.9 60.0
14.Secondary Outcome
Title Breakthrough on BI 201335/Placebo (Rebound While All 3 Treatments Were Still Ongoing)
Hide Description Number of patients with Unconfirmed rebound ( ≥ 1log10 increase in HCV mRNA) while on BI201335/placebo + 5 days washout.
Time Frame Up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 71 69 141 142 142 76 70
Measure Type: Number
Unit of Measure: percentage of patients
4.2 5.8 5.0 3.5 25.4 28.9 17.1
15.Secondary Outcome
Title Breakthrough on PegIFN/RBV (Rebound While Only PegIFN/RBV Treatment Alone Was Still Ongoing)
Hide Description Number of patients with Unconfirmed rebound (≥ 1log10 increase in HCV mRNA) while on PegIFN/RBV treatment + 5 days washout.
Time Frame Week 24 through Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 71 69 141 142 142 76 70
Measure Type: Number
Unit of Measure: percentage of patients
4.2 2.9 0.7 0.0 4.9 6.6 7.1
16.Secondary Outcome
Title Relapse
Hide Description

Relapse was rebound after the viral load at end of all treatment had been below the lower limit of detection, or, if the value at end of all treatment was missing, after both the last value before End of Treatment (EOT) and the first value after End of Treatment were below the lower limit of detection.

Patients could experience relapse at any point post-treatment.

Time Frame post-End of treatment (i.e. post 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 71 69 141 142 142 76 70
Measure Type: Number
Unit of Measure: percentage of patients
15.5 7.2 10.6 7.7 26.8 11.8 20.0
17.Secondary Outcome
Title Change From Baseline to Week 24 in Diastolic Blood Pressure and Systolic Blood Pressure
Hide Description Baseline is defined as the last value before the initial drug administration of BI 201335 or placebo.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Set (for patients with change from baseline in Systolic blood pressure and Diastolic blood pressure at Week 24)
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 61 60 115 130 102 55 42
Mean (Standard Deviation)
Unit of Measure: mmHg
Diastolic Blood Pressure -0.5  (9.11) 0.8  (12.41) -1.4  (10.87) -1.9  (10.19) -1.4  (9.34) -1.8  (10.39) -5.3  (10.27)
Systolic Blood Pressure -2.6  (11.48) -3.8  (15.51) -4.6  (14.59) -3.2  (13.63) -1.8  (14.21) -3.4  (12.85) -8.0  (14.38)
18.Secondary Outcome
Title Change From Baseline to Week 24 in Pulse Rate
Hide Description Baseline is defined as the last value before the administration of BI 201335 or placebo.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Set (for patients with change from baseline in Pulse rate at Week 24)
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 61 60 115 130 102 55 42
Mean (Standard Deviation)
Unit of Measure: bpm
4.1  (10.22) 3.1  (11.37) 4.1  (14.53) 5.3  (11.45) 5.5  (11.30) 7.6  (10.77) 3.1  (13.46)
19.Secondary Outcome
Title Change From Baseline to Week 24 in Weight of the Patients
Hide Description Baseline is defined as the last value before the administration of BI 201335 or placebo.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Set (for patients with change from baseline in Weight at Week 24)
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 61 60 115 130 101 55 42
Mean (Standard Deviation)
Unit of Measure: kg
-3.3  (3.11) -3.7  (3.14) -4.2  (3.81) -4.8  (5.07) -3.4  (3.36) -4.3  (3.67) -4.8  (4.40)
20.Secondary Outcome
Title Global Assessment of Tolerability
Hide Description

The investigator was to assess the tolerability of trial medication based on adverse events (AEs) and the laboratory evaluation.

Tolerability was assessed by the investigator according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'.

Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 71 69 141 142 142 76 70
Measure Type: Number
Unit of Measure: percentage of patients
Good 46.5 40.6 41.1 47.2 41.5 31.6 20.0
Satisfactory 33.8 36.2 36.2 31.7 33.1 40.8 37.1
Not satisfactory 8.5 11.6 12.1 12.0 13.4 14.5 22.9
Bad 5.6 2.9 5.0 6.3 9.2 9.2 20.0
Not assessable 1.4 2.9 4.3 0.0 1.4 0.0 0.0
Missing 4.2 5.8 1.4 2.8 1.4 3.9 0.0
21.Secondary Outcome
Title Change From Baseline to Week 24 in Haemoglobin of the Patients
Hide Description Baseline is defined as the last value before the administration of BI 201335 or placebo.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Set (for patients with change from baseline in Haemoglobin at Week 24)
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 60 59 114 129 103 55 40
Mean (Standard Deviation)
Unit of Measure: g/dL
-3.51  (1.526) -3.41  (1.406) -3.41  (1.177) -3.43  (1.493) -3.19  (1.447) -3.41  (1.285) -3.82  (1.997)
22.Secondary Outcome
Title Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Haemoglobin
Hide Description Number of patients with normal or high baseline moved to low .
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Set (for patients with normal or high baseline Haemoglobin)
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 70 67 137 146 139 76 67
Measure Type: Number
Unit of Measure: percentage of patients
64.3 62.7 51.1 53.4 45.3 63.2 53.7
23.Secondary Outcome
Title Change From Baseline to Week 24 in Absolute Neutrophils of the Patients
Hide Description Baseline is defined as the last value before the administration of BI 201335 or placebo.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Set (for patients with change from baseline in Absolute Neutrophils at Week 24)
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 58 58 111 129 102 55 39
Mean (Standard Deviation)
Unit of Measure: GI/L
-2.57  (1.784) -1.84  (1.497) -1.83  (2.788) -2.10  (1.551) -1.87  (1.567) -1.47  (1.680) -1.84  (1.885)
24.Secondary Outcome
Title Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Absolute Neutrophils
Hide Description Number of patients with normal or high baseline moved to low .
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Set (for patients with normal or high baseline Absolute Neutrophils)
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 68 65 134 139 126 66 57
Measure Type: Number
Unit of Measure: percentage of patients
70.6 66.2 47.8 45.3 50.0 54.5 47.4
25.Secondary Outcome
Title Change From Baseline to Week 24 in ALT/GPT,SGPT of the Patients
Hide Description Baseline is defined as the last value before the drug administration of BI 201335 or placebo.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Set (for patients with change from baseline in ALT/GPT,SGPT at Week 24)
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 60 60 116 130 102 55 42
Mean (Standard Deviation)
Unit of Measure: U/L
-92.0  (86.98) -67.7  (65.95) -64.2  (80.46) -70.2  (92.76) -50.8  (77.43) -62.0  (68.60) -61.0  (80.46)
26.Secondary Outcome
Title Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter ALT/GPT,SGPT
Hide Description Number of patients with normal or low baseline moved to high .
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Set (for patients with normal or low baseline ALT/GPT,SGPT)
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 11 10 32 26 24 6 10
Measure Type: Number
Unit of Measure: percentage of patients
0.0 10.0 3.1 0.0 8.3 16.7 20.0
27.Secondary Outcome
Title Change From Baseline to Week 24 in Total Bilirubin of the Patients
Hide Description Baseline is defined as the last value before the administration of BI 201335 or placebo.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Set (for patients with change from baseline in Total Bilirubin at Week 24)
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 61 60 116 130 103 55 42
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.03  (0.181) 0.70  (0.625) 1.65  (1.279) 1.51  (0.983) 1.37  (0.959) 1.09  (0.996) 3.04  (2.203)
28.Secondary Outcome
Title Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Total Bilirubin
Hide Description Number of patients with normal or low baseline moved to high .
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Set (for patients with normal or low baseline Total Bilirubin)
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 69 66 132 146 136 74 68
Measure Type: Number
Unit of Measure: percentage of patients
0.0 9.1 15.9 8.9 29.4 17.6 33.8
29.Secondary Outcome
Title Trough Concentration (Cpre,ss) of Faldaprevir at Steady State
Hide Description C(pre,ss) is defined as pre-dose (trough) concentration of Faldaprevir in plasma at steady state immediately before administration of the next dose.
Time Frame Week 8, week 10, week 12, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.
Arm/Group Title 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 69 143 146 142 76 70
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
week 8(N=52,108,116,107,47,32)
1310
(81.7%)
6550
(106%)
6190
(169%)
7230
(94.3%)
6410
(95.4%)
51100
(55.1%)
week 10(N=54,98,101,94,54,29)
1220
(91.3%)
6530
(118%)
6340
(99.7%)
6370
(137%)
7020
(108%)
43500
(72.2%)
week 12(N=53,113,119,105,56,30)
1240
(91.1%)
6380
(125%)
6780
(100%)
6400
(123%)
5980
(91.2%)
46300
(58.7%)
week 24(N=47,86,95,78,39,26)
1170
(142%)
6440
(109%)
6610
(132%)
6630
(102%)
4280
(179%)
33900
(509%)
30.Secondary Outcome
Title Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1000 mg/Day RBV)
Hide Description C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose.
Time Frame Week 8, week 10, week 12, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 71 69 143 146 142 76 70
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
week 8(N=23,25,46,43,38,20,12)
2260
(26.6%)
1920
(37.9%)
2320
(30.8%)
2200
(28.7%)
2150
(26.4%)
2090
(26.0%)
2180
(27.1%)
week 10(N=22,27,50,38,34,25,11)
2210
(28.2%)
1960
(33.3%)
2290
(30.8%)
2330
(23.8%)
2190
(28.9%)
2140
(24.6%)
2300
(21.5%)
week 12(N=22,27,45,47,37,21,11)
2200
(25.1%)
2060
(35.9%)
2290
(33.6%)
2340
(29.5%)
2140
(28.2%)
2150
(23.6%)
2300
(27.3%)
week 24(N=21,18,37,34,28,16,11)
2370
(34.6%)
2100
(45.3%)
2390
(29.6%)
2260
(37.3%)
1960
(35.5%)
2270
(25.0%)
1970
(47.1%)
31.Secondary Outcome
Title Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1200 mg/Day RBV)
Hide Description C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose.
Time Frame Week 8, week 10, week 12, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 71 69 143 146 142 76 70
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
week 8(N=24,21,45,48,49,25,23)
1670
(118%)
2010
(30.4%)
2060
(26.5%)
2170
(30.4%)
2060
(30.5%)
2170
(40.2%)
1880
(37.2%)
week 10(N=27,22,43,45,47,22,22)
1780
(97.3%)
1970
(28.5%)
2100
(26.1%)
2280
(26.5%)
2090
(30.5%)
1980
(35.3%)
2090
(34.4%)
week 12(N=27,21,46,47,44,25,22)
1880
(59.1%)
1900
(37.0%)
2090
(21.7%)
2260
(26.0%)
2190
(29.0%)
2010
(33.2%)
1950
(24.9%)
week 24(N=21,19,33,39,38,18,17)
2030
(27.0%)
2390
(23.3%)
1970
(32.2%)
2250
(23.0%)
2180
(27.7%)
2050
(31.9%)
2220
(29.7%)
32.Secondary Outcome
Title Trough Concentration (Cpre,ss) of PegIFN at Steady State
Hide Description C(pre,ss) is defined as pre-dose (trough) concentration of PegIFN in plasma at steady state immediately before administration of the next dose.
Time Frame Week 8, week 10, week 12, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.
Arm/Group Title Placebo-TN 120 mg QD / LI-TN 240 mg QD / LI-TN 240 mg QD-TN 240 mg QD / LI-TE 240 mg QD-TE 240 mg BID / LI-TE
Hide Arm/Group Description:

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

Overall Number of Participants Analyzed 71 69 143 146 142 76 70
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
week 8(N=55,46,80,91,80,36,33)
14500
(83.9%)
14800
(59.9%)
14900
(41.1%)
15100
(58.5%)
11300
(151%)
11100
(125%)
12300
(95.1%)
week 10(N=46,48,88,94,80,40,33)
14700
(86.6%)
13400
(87.1%)
14600
(70.2%)
15500
(52.2%)
11300
(144%)
11600
(155%)
12500
(85.4%)
week 12(N=54,51,100,107,105,56,42)
15600
(77.9%)
13000
(102%)
13700
(89.4%)
14600
(70.5%)
13100
(105%)
13800
(110%)
13500
(102%)
week 24(N=49,42,74,87,75,40,38)
17300
(45.4%)
17200
(83.8%)
16900
(42.2%)
16700
(50.3%)
15600
(44.0%)
15300
(63.3%)
15700
(38.5%)
Time Frame Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120.
Adverse Event Reporting Description In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
 
Arm/Group Title Placebo-TN 120mg QD/LI-TN 240mg QD/LI-TN 240mg QD-TN 240mg QD/LI-TE 240mg QD-TE 240mg BID/LI-TE
Hide Arm/Group Description

Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients

[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]

All-Cause Mortality
Placebo-TN 120mg QD/LI-TN 240mg QD/LI-TN 240mg QD-TN 240mg QD/LI-TE 240mg QD-TE 240mg BID/LI-TE
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo-TN 120mg QD/LI-TN 240mg QD/LI-TN 240mg QD-TN 240mg QD/LI-TE 240mg QD-TE 240mg BID/LI-TE
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/71 (2.82%)   3/68 (4.41%)   18/138 (13.04%)   12/149 (8.05%)   10/141 (7.09%)   5/76 (6.58%)   13/69 (18.84%) 
Blood and lymphatic system disorders               
Anaemia  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  1/141 (0.71%)  0/76 (0.00%)  3/69 (4.35%) 
Anaemia haemolytic autoimmune  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  1/141 (0.71%)  0/76 (0.00%)  0/69 (0.00%) 
Febrile neutropenia  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  1/149 (0.67%)  0/141 (0.00%)  1/76 (1.32%)  0/69 (0.00%) 
Lymphopenia  1  0/71 (0.00%)  1/68 (1.47%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Thrombocytopenia  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  1/149 (0.67%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Cardiac disorders               
Angina pectoris  1  0/71 (0.00%)  0/68 (0.00%)  1/138 (0.72%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Microvascular angina  1  0/71 (0.00%)  0/68 (0.00%)  1/138 (0.72%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Myocardial infarction  1  0/71 (0.00%)  0/68 (0.00%)  1/138 (0.72%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Prinzmetal angina  1  0/71 (0.00%)  1/68 (1.47%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Eye disorders               
Cataract  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  1/149 (0.67%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Photophobia  1  1/71 (1.41%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Gastrointestinal disorders               
Anal fistula  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  1/141 (0.71%)  0/76 (0.00%)  0/69 (0.00%) 
Diarrhoea  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  1/69 (1.45%) 
Haemorrhoids  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  1/69 (1.45%) 
Mouth ulceration  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  1/69 (1.45%) 
Nausea  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  1/69 (1.45%) 
Rectal haemorrhage  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  1/149 (0.67%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Upper gastrointestinal haemorrhage  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  1/141 (0.71%)  0/76 (0.00%)  0/69 (0.00%) 
Vomiting  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  2/69 (2.90%) 
General disorders               
Asthenia  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  1/69 (1.45%) 
Chest discomfort  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  1/76 (1.32%)  0/69 (0.00%) 
Chest pain  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  1/69 (1.45%) 
Cyst  1  1/71 (1.41%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Fatigue  1  0/71 (0.00%)  0/68 (0.00%)  1/138 (0.72%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Mucosal inflammation  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  1/69 (1.45%) 
Oedema peripheral  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  1/69 (1.45%) 
Pyrexia  1  0/71 (0.00%)  0/68 (0.00%)  2/138 (1.45%)  1/149 (0.67%)  1/141 (0.71%)  0/76 (0.00%)  0/69 (0.00%) 
Hepatobiliary disorders               
Cholecystitis  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  1/69 (1.45%) 
Gallbladder polyp  1  0/71 (0.00%)  0/68 (0.00%)  1/138 (0.72%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Immune system disorders               
Cryoglobulinaemia  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  1/141 (0.71%)  0/76 (0.00%)  0/69 (0.00%) 
Infections and infestations               
Anal abscess  1  0/71 (0.00%)  0/68 (0.00%)  1/138 (0.72%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Ear infection  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  1/69 (1.45%) 
H1N1 influenza  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  1/141 (0.71%)  0/76 (0.00%)  1/69 (1.45%) 
Infected skin ulcer  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  1/69 (1.45%) 
Influenza  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  1/76 (1.32%)  0/69 (0.00%) 
Lower respiratory tract infection  1  0/71 (0.00%)  0/68 (0.00%)  1/138 (0.72%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Lymphangitis  1  0/71 (0.00%)  0/68 (0.00%)  1/138 (0.72%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Oral herpes  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  1/69 (1.45%) 
Perirectal abscess  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  1/69 (1.45%) 
Pharyngitis  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  1/69 (1.45%) 
Pneumonia  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  1/149 (0.67%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Pyelonephritis  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  1/141 (0.71%)  0/76 (0.00%)  0/69 (0.00%) 
Subcutaneous abscess  1  0/71 (0.00%)  0/68 (0.00%)  1/138 (0.72%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Superinfection bacterial  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  1/149 (0.67%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Upper respiratory tract infection  1  0/71 (0.00%)  0/68 (0.00%)  1/138 (0.72%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Urinary tract infection  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  1/141 (0.71%)  0/76 (0.00%)  0/69 (0.00%) 
Injury, poisoning and procedural complications               
Road traffic accident  1  0/71 (0.00%)  0/68 (0.00%)  1/138 (0.72%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Metabolism and nutrition disorders               
Dehydration  1  0/71 (0.00%)  0/68 (0.00%)  1/138 (0.72%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  1/69 (1.45%) 
Diabetes mellitus  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  1/149 (0.67%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Musculoskeletal and connective tissue disorders               
Intervertebral disc protrusion  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  1/69 (1.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Benign salivary gland neoplasm  1  1/71 (1.41%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Nervous system disorders               
Headache  1  1/71 (1.41%)  0/68 (0.00%)  1/138 (0.72%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  1/69 (1.45%) 
Ischaemic stroke  1  0/71 (0.00%)  0/68 (0.00%)  1/138 (0.72%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Migraine  1  1/71 (1.41%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Syncope  1  0/71 (0.00%)  1/68 (1.47%)  0/138 (0.00%)  0/149 (0.00%)  1/141 (0.71%)  0/76 (0.00%)  0/69 (0.00%) 
Psychiatric disorders               
Acute psychosis  1  0/71 (0.00%)  0/68 (0.00%)  1/138 (0.72%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Depressed mood  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  1/76 (1.32%)  0/69 (0.00%) 
Depression  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  1/149 (0.67%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Suicide attempt  1  0/71 (0.00%)  0/68 (0.00%)  1/138 (0.72%)  0/149 (0.00%)  1/141 (0.71%)  0/76 (0.00%)  0/69 (0.00%) 
Renal and urinary disorders               
Calculus ureteric  1  0/71 (0.00%)  0/68 (0.00%)  1/138 (0.72%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Reproductive system and breast disorders               
Endometrial hyperplasia  1  0/71 (0.00%)  0/68 (0.00%)  1/138 (0.72%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Pulmonary embolism  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  1/69 (1.45%) 
Skin and subcutaneous tissue disorders               
Dermatitis atopic  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  1/149 (0.67%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Drug eruption  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  2/149 (1.34%)  0/141 (0.00%)  1/76 (1.32%)  0/69 (0.00%) 
Eczema  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  1/149 (0.67%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Erythema multiforme  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  1/69 (1.45%) 
Lichen planus  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  1/76 (1.32%)  0/69 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  1/149 (0.67%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Parapsoriasis  1  0/71 (0.00%)  0/68 (0.00%)  1/138 (0.72%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Photosensitivity reaction  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  1/149 (0.67%)  0/141 (0.00%)  0/76 (0.00%)  1/69 (1.45%) 
Pruritus allergic  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  1/76 (1.32%)  0/69 (0.00%) 
Rash  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  1/69 (1.45%) 
Rash erythematous  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  1/76 (1.32%)  0/69 (0.00%) 
Rash maculo-papular  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  1/76 (1.32%)  1/69 (1.45%) 
Rash pruritic  1  0/71 (0.00%)  0/68 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  0/141 (0.00%)  1/76 (1.32%)  0/69 (0.00%) 
Surgical and medical procedures               
Appendicectomy  1  0/71 (0.00%)  0/68 (0.00%)  1/138 (0.72%)  0/149 (0.00%)  0/141 (0.00%)  0/76 (0.00%)  0/69 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo-TN 120mg QD/LI-TN 240mg QD/LI-TN 240mg QD-TN 240mg QD/LI-TE 240mg QD-TE 240mg BID/LI-TE
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   65/71 (91.55%)   65/68 (95.59%)   135/138 (97.83%)   143/149 (95.97%)   135/141 (95.74%)   74/76 (97.37%)   68/69 (98.55%) 
Blood and lymphatic system disorders               
Anaemia  1  12/71 (16.90%)  14/68 (20.59%)  16/138 (11.59%)  22/149 (14.77%)  10/141 (7.09%)  10/76 (13.16%)  13/69 (18.84%) 
Neutropenia  1  8/71 (11.27%)  9/68 (13.24%)  11/138 (7.97%)  9/149 (6.04%)  7/141 (4.96%)  10/76 (13.16%)  3/69 (4.35%) 
Eye disorders               
Dry eye  1  2/71 (2.82%)  1/68 (1.47%)  7/138 (5.07%)  4/149 (2.68%)  8/141 (5.67%)  3/76 (3.95%)  3/69 (4.35%) 
Ocular icterus  1  1/71 (1.41%)  1/68 (1.47%)  8/138 (5.80%)  2/149 (1.34%)  2/141 (1.42%)  8/76 (10.53%)  6/69 (8.70%) 
Vision blurred  1  0/71 (0.00%)  2/68 (2.94%)  4/138 (2.90%)  2/149 (1.34%)  7/141 (4.96%)  0/76 (0.00%)  0/69 (0.00%) 
Gastrointestinal disorders               
Abdominal discomfort  1  2/71 (2.82%)  1/68 (1.47%)  1/138 (0.72%)  7/149 (4.70%)  10/141 (7.09%)  1/76 (1.32%)  0/69 (0.00%) 
Abdominal distension  1  0/71 (0.00%)  1/68 (1.47%)  2/138 (1.45%)  10/149 (6.71%)  1/141 (0.71%)  0/76 (0.00%)  1/69 (1.45%) 
Abdominal pain  1  6/71 (8.45%)  4/68 (5.88%)  9/138 (6.52%)  6/149 (4.03%)  10/141 (7.09%)  0/76 (0.00%)  2/69 (2.90%) 
Abdominal pain upper  1  3/71 (4.23%)  6/68 (8.82%)  9/138 (6.52%)  14/149 (9.40%)  11/141 (7.80%)  10/76 (13.16%)  11/69 (15.94%) 
Cheilitis  1  0/71 (0.00%)  1/68 (1.47%)  0/138 (0.00%)  5/149 (3.36%)  3/141 (2.13%)  1/76 (1.32%)  5/69 (7.25%) 
Constipation  1  1/71 (1.41%)  5/68 (7.35%)  6/138 (4.35%)  3/149 (2.01%)  7/141 (4.96%)  2/76 (2.63%)  6/69 (8.70%) 
Diarrhoea  1  13/71 (18.31%)  9/68 (13.24%)  44/138 (31.88%)  40/149 (26.85%)  45/141 (31.91%)  24/76 (31.58%)  26/69 (37.68%) 
Dry mouth  1  2/71 (2.82%)  3/68 (4.41%)  7/138 (5.07%)  9/149 (6.04%)  10/141 (7.09%)  1/76 (1.32%)  3/69 (4.35%) 
Dyspepsia  1  4/71 (5.63%)  3/68 (4.41%)  18/138 (13.04%)  13/149 (8.72%)  10/141 (7.09%)  5/76 (6.58%)  8/69 (11.59%) 
Gastrooesophageal reflux disease  1  2/71 (2.82%)  2/68 (2.94%)  4/138 (2.90%)  1/149 (0.67%)  6/141 (4.26%)  0/76 (0.00%)  4/69 (5.80%) 
Nausea  1  14/71 (19.72%)  17/68 (25.00%)  65/138 (47.10%)  66/149 (44.30%)  68/141 (48.23%)  40/76 (52.63%)  43/69 (62.32%) 
Toothache  1  1/71 (1.41%)  4/68 (5.88%)  2/138 (1.45%)  5/149 (3.36%)  0/141 (0.00%)  3/76 (3.95%)  0/69 (0.00%) 
Vomiting  1  4/71 (5.63%)  14/68 (20.59%)  25/138 (18.12%)  34/149 (22.82%)  24/141 (17.02%)  17/76 (22.37%)  21/69 (30.43%) 
General disorders               
Asthenia  1  15/71 (21.13%)  10/68 (14.71%)  33/138 (23.91%)  41/149 (27.52%)  34/141 (24.11%)  15/76 (19.74%)  19/69 (27.54%) 
Chills  1  8/71 (11.27%)  4/68 (5.88%)  14/138 (10.14%)  16/149 (10.74%)  10/141 (7.09%)  9/76 (11.84%)  1/69 (1.45%) 
Fatigue  1  24/71 (33.80%)  19/68 (27.94%)  32/138 (23.19%)  39/149 (26.17%)  49/141 (34.75%)  30/76 (39.47%)  25/69 (36.23%) 
Influenza like illness  1  34/71 (47.89%)  26/68 (38.24%)  48/138 (34.78%)  55/149 (36.91%)  44/141 (31.21%)  21/76 (27.63%)  23/69 (33.33%) 
Injection site erythema  1  7/71 (9.86%)  3/68 (4.41%)  7/138 (5.07%)  9/149 (6.04%)  8/141 (5.67%)  1/76 (1.32%)  3/69 (4.35%) 
Irritability  1  10/71 (14.08%)  8/68 (11.76%)  15/138 (10.87%)  13/149 (8.72%)  27/141 (19.15%)  12/76 (15.79%)  7/69 (10.14%) 
Pyrexia  1  11/71 (15.49%)  10/68 (14.71%)  26/138 (18.84%)  30/149 (20.13%)  25/141 (17.73%)  12/76 (15.79%)  16/69 (23.19%) 
Hepatobiliary disorders               
Hyperbilirubinaemia  1  0/71 (0.00%)  3/68 (4.41%)  13/138 (9.42%)  3/149 (2.01%)  2/141 (1.42%)  4/76 (5.26%)  0/69 (0.00%) 
Jaundice  1  1/71 (1.41%)  4/68 (5.88%)  27/138 (19.57%)  37/149 (24.83%)  25/141 (17.73%)  10/76 (13.16%)  26/69 (37.68%) 
Infections and infestations               
Herpes simplex  1  4/71 (5.63%)  1/68 (1.47%)  0/138 (0.00%)  1/149 (0.67%)  1/141 (0.71%)  1/76 (1.32%)  0/69 (0.00%) 
Influenza  1  0/71 (0.00%)  4/68 (5.88%)  4/138 (2.90%)  6/149 (4.03%)  4/141 (2.84%)  1/76 (1.32%)  5/69 (7.25%) 
Injury, poisoning and procedural complications               
Sunburn  1  0/71 (0.00%)  1/68 (1.47%)  3/138 (2.17%)  7/149 (4.70%)  6/141 (4.26%)  2/76 (2.63%)  5/69 (7.25%) 
Investigations               
Blood bilirubin increased  1  0/71 (0.00%)  0/68 (0.00%)  1/138 (0.72%)  1/149 (0.67%)  2/141 (1.42%)  2/76 (2.63%)  4/69 (5.80%) 
Haemoglobin decreased  1  4/71 (5.63%)  2/68 (2.94%)  1/138 (0.72%)  6/149 (4.03%)  3/141 (2.13%)  2/76 (2.63%)  0/69 (0.00%) 
Weight decreased  1  4/71 (5.63%)  3/68 (4.41%)  9/138 (6.52%)  10/149 (6.71%)  7/141 (4.96%)  5/76 (6.58%)  7/69 (10.14%) 
Metabolism and nutrition disorders               
Decreased appetite  1  11/71 (15.49%)  16/68 (23.53%)  28/138 (20.29%)  31/149 (20.81%)  28/141 (19.86%)  14/76 (18.42%)  16/69 (23.19%) 
Musculoskeletal and connective tissue disorders               
Arthralgia  1  5/71 (7.04%)  11/68 (16.18%)  15/138 (10.87%)  16/149 (10.74%)  13/141 (9.22%)  11/76 (14.47%)  6/69 (8.70%) 
Back pain  1  3/71 (4.23%)  6/68 (8.82%)  10/138 (7.25%)  7/149 (4.70%)  12/141 (8.51%)  2/76 (2.63%)  4/69 (5.80%) 
Bone pain  1  0/71 (0.00%)  5/68 (7.35%)  1/138 (0.72%)  4/149 (2.68%)  1/141 (0.71%)  1/76 (1.32%)  2/69 (2.90%) 
Muscle spasms  1  0/71 (0.00%)  0/68 (0.00%)  6/138 (4.35%)  6/149 (4.03%)  9/141 (6.38%)  6/76 (7.89%)  3/69 (4.35%) 
Myalgia  1  12/71 (16.90%)  14/68 (20.59%)  26/138 (18.84%)  35/149 (23.49%)  24/141 (17.02%)  17/76 (22.37%)  17/69 (24.64%) 
Neck pain  1  1/71 (1.41%)  0/68 (0.00%)  2/138 (1.45%)  3/149 (2.01%)  1/141 (0.71%)  3/76 (3.95%)  4/69 (5.80%) 
Pain in extremity  1  1/71 (1.41%)  4/68 (5.88%)  3/138 (2.17%)  4/149 (2.68%)  2/141 (1.42%)  1/76 (1.32%)  2/69 (2.90%) 
Nervous system disorders               
Disturbance in attention  1  3/71 (4.23%)  2/68 (2.94%)  5/138 (3.62%)  2/149 (1.34%)  8/141 (5.67%)  3/76 (3.95%)  3/69 (4.35%) 
Dizziness  1  5/71 (7.04%)  4/68 (5.88%)  9/138 (6.52%)  10/149 (6.71%)  16/141 (11.35%)  4/76 (5.26%)  5/69 (7.25%) 
Dysgeusia  1  0/71 (0.00%)  3/68 (4.41%)  4/138 (2.90%)  2/149 (1.34%)  8/141 (5.67%)  3/76 (3.95%)  5/69 (7.25%) 
Headache  1  27/71 (38.03%)  28/68 (41.18%)  46/138 (33.33%)  51/149 (34.23%)  56/141 (39.72%)  32/76 (42.11%)  30/69 (43.48%) 
Lethargy  1  5/71 (7.04%)  3/68 (4.41%)  5/138 (3.62%)  3/149 (2.01%)  2/141 (1.42%)  0/76 (0.00%)  1/69 (1.45%) 
Paraesthesia  1  2/71 (2.82%)  1/68 (1.47%)  2/138 (1.45%)  0/149 (0.00%)  3/141 (2.13%)  1/76 (1.32%)  4/69 (5.80%) 
Psychiatric disorders               
Anxiety  1  3/71 (4.23%)  3/68 (4.41%)  5/138 (3.62%)  6/149 (4.03%)  11/141 (7.80%)  4/76 (5.26%)  2/69 (2.90%) 
Depressed mood  1  3/71 (4.23%)  0/68 (0.00%)  2/138 (1.45%)  3/149 (2.01%)  6/141 (4.26%)  2/76 (2.63%)  5/69 (7.25%) 
Depression  1  7/71 (9.86%)  9/68 (13.24%)  16/138 (11.59%)  17/149 (11.41%)  19/141 (13.48%)  3/76 (3.95%)  4/69 (5.80%) 
Insomnia  1  17/71 (23.94%)  12/68 (17.65%)  22/138 (15.94%)  28/149 (18.79%)  30/141 (21.28%)  12/76 (15.79%)  14/69 (20.29%) 
Mood swings  1  5/71 (7.04%)  1/68 (1.47%)  2/138 (1.45%)  3/149 (2.01%)  1/141 (0.71%)  5/76 (6.58%)  1/69 (1.45%) 
Sleep disorder  1  3/71 (4.23%)  3/68 (4.41%)  16/138 (11.59%)  12/149 (8.05%)  9/141 (6.38%)  8/76 (10.53%)  6/69 (8.70%) 
Respiratory, thoracic and mediastinal disorders               
Cough  1  9/71 (12.68%)  9/68 (13.24%)  22/138 (15.94%)  18/149 (12.08%)  25/141 (17.73%)  13/76 (17.11%)  13/69 (18.84%) 
Dyspnoea  1  11/71 (15.49%)  9/68 (13.24%)  13/138 (9.42%)  13/149 (8.72%)  24/141 (17.02%)  7/76 (9.21%)  7/69 (10.14%) 
Dyspnoea exertional  1  3/71 (4.23%)  0/68 (0.00%)  8/138 (5.80%)  8/149 (5.37%)  6/141 (4.26%)  2/76 (2.63%)  0/69 (0.00%) 
Skin and subcutaneous tissue disorders               
Alopecia  1  8/71 (11.27%)  16/68 (23.53%)  29/138 (21.01%)  23/149 (15.44%)  17/141 (12.06%)  9/76 (11.84%)  12/69 (17.39%) 
Dry skin  1  10/71 (14.08%)  16/68 (23.53%)  25/138 (18.12%)  22/149 (14.77%)  26/141 (18.44%)  13/76 (17.11%)  20/69 (28.99%) 
Eczema  1  3/71 (4.23%)  4/68 (5.88%)  9/138 (6.52%)  7/149 (4.70%)  4/141 (2.84%)  5/76 (6.58%)  4/69 (5.80%) 
Erythema  1  0/71 (0.00%)  2/68 (2.94%)  8/138 (5.80%)  9/149 (6.04%)  6/141 (4.26%)  6/76 (7.89%)  4/69 (5.80%) 
Hyperhidrosis  1  0/71 (0.00%)  4/68 (5.88%)  1/138 (0.72%)  1/149 (0.67%)  7/141 (4.96%)  1/76 (1.32%)  0/69 (0.00%) 
Photosensitivity reaction  1  1/71 (1.41%)  1/68 (1.47%)  13/138 (9.42%)  14/149 (9.40%)  19/141 (13.48%)  10/76 (13.16%)  19/69 (27.54%) 
Pruritus  1  12/71 (16.90%)  22/68 (32.35%)  49/138 (35.51%)  56/149 (37.58%)  43/141 (30.50%)  34/76 (44.74%)  23/69 (33.33%) 
Rash  1  12/71 (16.90%)  14/68 (20.59%)  39/138 (28.26%)  40/149 (26.85%)  35/141 (24.82%)  14/76 (18.42%)  21/69 (30.43%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00774397     History of Changes
Other Study ID Numbers: 1220.5
2008-003538-11 ( EudraCT Number: EudraCT )
First Submitted: October 16, 2008
First Posted: October 17, 2008
Results First Submitted: July 3, 2015
Results First Posted: November 16, 2015
Last Update Posted: November 16, 2015