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Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)

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ClinicalTrials.gov Identifier: NCT01358864
Recruitment Status : Completed
First Posted : May 24, 2011
Results First Posted : October 28, 2015
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: BI 201335
Drug: Pegylated Interferon-alpha (IFN)
Drug: Ribavirin (RBV)
Drug: Placebo
Enrollment 678
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Relapser:Placebo Relapser:Faldaprevir 12 Weeks Relapser:Faldaprevir 24 Weeks Partial:Placebo Partial:Faldaprevir 12 Weeks Partial:Faldaprevir 24 Weeks Null:Faldaprevir 12 Weeks Null:Faldaprevir 24 Weeks
Hide Arm/Group Description Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks. Patients who had had a prior relapse, received Faldaprevir (BI 201335) 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone. Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone. Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks. Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks. Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks. Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks. Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Period Title: Overall Study
Started 49 99 103 29 57 55 146 140
Completed 18 86 87 10 46 42 81 85
Not Completed 31 13 16 19 11 13 65 55
Reason Not Completed
Adverse Event             0             6             9             0             4             8             12             7
Lack of Efficacy             26             3             4             19             7             4             49             44
Lost to Follow-up             0             0             1             0             0             0             0             1
Withdrawal by Subject             3             4             2             0             0             1             1             3
Other reason not defined above             2             0             0             0             0             0             2             0
Not treated             0             0             0             0             0             0             1             0
Arm/Group Title Relapser:Placebo Relapser:Faldaprevir 12 Weeks Relapser:Faldaprevir 24 Weeks Partial:Placebo Partial:Faldaprevir 12 Weeks Partial:Faldaprevir 24 Weeks Null:Faldaprevir 12 Weeks Null:Faldaprevir 24 Weeks Total
Hide Arm/Group Description Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks. Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone. Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone. Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks. Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks. Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks. Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks. Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 49 99 103 29 57 55 145 140 677
Hide Baseline Analysis Population Description
Full Analysis Set (FAS)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 99 participants 103 participants 29 participants 57 participants 55 participants 145 participants 140 participants 677 participants
53.4  (8.29) 53.5  (8.57) 53.7  (8.14) 55.7  (7.50) 52.7  (7.90) 52.0  (10.32) 53.2  (8.76) 53.6  (8.13) 53.4  (8.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 99 participants 103 participants 29 participants 57 participants 55 participants 145 participants 140 participants 677 participants
Female
20
  40.8%
44
  44.4%
43
  41.7%
10
  34.5%
20
  35.1%
20
  36.4%
54
  37.2%
63
  45.0%
274
  40.5%
Male
29
  59.2%
55
  55.6%
60
  58.3%
19
  65.5%
37
  64.9%
35
  63.6%
91
  62.8%
77
  55.0%
403
  59.5%
1.Primary Outcome
Title Sustained Virological Response 12 Weeks Post Treatment (SVR12)
Hide Description Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
Time Frame 12 weeks post treatment, up to 60 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Relapser & Partial: Placebo Relapser & Partial: Faldaprevir 12 Weeks Relapser & Partial: Faldaprevir 24 Weeks Null:Faldaprevir 12 Weeks Null:Faldaprevir 24 Weeks
Hide Arm/Group Description:
Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Overall Number of Participants Analyzed 78 156 158 145 140
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
10.3
(3.5 to 17.0)
65.4
(57.9 to 72.9)
61.4
(53.8 to 69.0)
33.8
(26.1 to 41.5)
32.9
(25.1 to 40.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relapser & Partial: Placebo, Relapser & Partial: Faldaprevir 12 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted for genotype and previous response to treatment
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percent difference
Estimated Value 54.7
Confidence Interval (2-Sided) 95%
44.4 to 65.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relapser & Partial: Placebo, Relapser & Partial: Faldaprevir 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted for genotype and previous response to treatment
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percent difference
Estimated Value 50.4
Confidence Interval (2-Sided) 95%
40.1 to 60.8
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Relapser & Partial: Faldaprevir 12 Weeks, Relapser & Partial: Faldaprevir 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percent difference
Estimated Value 4.5
Confidence Interval (2-Sided) 95%
-5.8 to 14.9
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Null:Faldaprevir 12 Weeks, Null:Faldaprevir 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percent difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-10.9 to 10.7
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Null:Faldaprevir 12 Weeks
Comments Comparison is based on the Null:Faldaprevir 12 weeks vs historical rate of 20%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Normal approximation
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Null:Faldaprevir 24 Weeks
Comments Comparison is based on the Null:Faldaprevir 24 weeks vs historical rate of 20%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Normal approximation
Comments [Not Specified]
2.Secondary Outcome
Title Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)
Hide Description Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.
Time Frame 24 weeks post treatment, up to 72 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Relapser & Partial: Placebo Relapser & Partial: Faldaprevir 12 Weeks Relapser & Partial: Faldaprevir 24 Weeks Null:Faldaprevir 12 Weeks Null:Faldaprevir 24 Weeks
Hide Arm/Group Description:
Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Overall Number of Participants Analyzed 78 156 158 145 140
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
10.3
(3.5 to 17.0)
63.5
(55.9 to 71.0)
59.5
(51.8 to 67.1)
33.8
(26.1 to 41.5)
32.9
(25.1 to 40.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relapser & Partial: Placebo, Relapser & Partial: Faldaprevir 12 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted for genotype and previous response to treatment
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percent difference
Estimated Value 52.8
Confidence Interval (2-Sided) 95%
42.4 to 63.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relapser & Partial: Placebo, Relapser & Partial: Faldaprevir 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted for genotype and previous response to treatment
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percent difference
Estimated Value 48.5
Confidence Interval (2-Sided) 95%
38.2 to 58.9
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Relapser & Partial: Faldaprevir 12 Weeks, Relapser & Partial: Faldaprevir 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percent difference
Estimated Value 4.4
Confidence Interval (2-Sided) 95%
-6.0 to 14.9
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Null:Faldaprevir 12 Weeks, Null:Faldaprevir 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted percent difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-10.9 to 10.7
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Null:Faldaprevir 12 Weeks
Comments Comparison is based on the Null:Faldaprevir 12 weeks vs historical rate of 20%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Normal approximation
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Null:Faldaprevir 24 Weeks
Comments Comparison is based on the Null:Faldaprevir 24 weeks vs historical rate of 20%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Normal approximation
Comments [Not Specified]
3.Secondary Outcome
Title Early Treatment Success (ETS)
Hide Description Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level <25 IU/mL (undetected or detected) at Week 4 and <25 IU/mL (undetected) at Week 8.
Time Frame Week 4 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Relapser:Placebo Relapser:Faldaprevir 12 Weeks Relapser:Faldaprevir 24 Weeks Partial:Placebo Partial:Faldaprevir 12 Weeks Partial:Faldaprevir 24 Weeks Null:Faldaprevir 12 Weeks Null:Faldaprevir 24 Weeks
Hide Arm/Group Description:
Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Overall Number of Participants Analyzed 49 99 103 29 57 55 145 140
Measure Type: Number
Unit of Measure: percentage of participants
4.1 85.9 87.4 3.4 66.7 76.4 58.6 51.4
4.Secondary Outcome
Title ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO
Hide Description The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment (EoT) when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame End of treatment, up to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Relapser:Placebo Relapser:Faldaprevir 12 Weeks Relapser:Faldaprevir 24 Weeks Partial:Placebo Partial:Faldaprevir 12 Weeks Partial:Faldaprevir 24 Weeks Null:Faldaprevir 12 Weeks Null:Faldaprevir 24 Weeks
Hide Arm/Group Description:
Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Overall Number of Participants Analyzed 49 99 103 29 57 55 145 140
Measure Type: Number
Unit of Measure: participants
SVR12=NO 42 30 31 28 24 30 96 94
BL normal to EoT normal 9 9 6 3 4 4 15 14
BL elevated to EoT normal 15 10 14 9 14 6 34 38
No EoT data available for ALT 1 0 0 0 0 1 1 0
5.Secondary Outcome
Title ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES
Hide Description The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame End of treatment, up to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Relapser:Placebo Relapser:Faldaprevir 12 Weeks Relapser:Faldaprevir 24 Weeks Partial:Placebo Partial:Faldaprevir 12 Weeks Partial:Faldaprevir 24 Weeks Null:Faldaprevir 12 Weeks Null:Faldaprevir 24 Weeks
Hide Arm/Group Description:
Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Overall Number of Participants Analyzed 49 99 103 29 57 55 145 140
Measure Type: Number
Unit of Measure: participants
SVR12=YES 7 69 72 1 33 25 49 46
BL normal to EoT normal 3 30 30 0 10 8 12 9
BL elevated to EoT normal 4 29 26 1 14 8 23 27
6.Secondary Outcome
Title AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO
Hide Description The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame End of treatment, up to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Relapser:Placebo Relapser:Faldaprevir 12 Weeks Relapser:Faldaprevir 24 Weeks Partial:Placebo Partial:Faldaprevir 12 Weeks Partial:Faldaprevir 24 Weeks Null:Faldaprevir 12 Weeks Null:Faldaprevir 24 Weeks
Hide Arm/Group Description:
Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Overall Number of Participants Analyzed 49 99 103 29 57 55 145 140
Measure Type: Number
Unit of Measure: participants
SVR12=NO 42 30 31 28 24 30 96 94
BL normal to EoT normal 19 16 12 4 3 5 18 21
BL elevated to EoT normal 5 5 9 9 14 6 24 28
7.Secondary Outcome
Title AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES
Hide Description The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment (EoT) when patients have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame End of treatment, up to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Relapser:Placebo Relapser:Faldaprevir 12 Weeks Relapser:Faldaprevir 24 Weeks Partial:Placebo Partial:Faldaprevir 12 Weeks Partial:Faldaprevir 24 Weeks Null:Faldaprevir 12 Weeks Null:Faldaprevir 24 Weeks
Hide Arm/Group Description:
Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Overall Number of Participants Analyzed 49 99 103 29 57 55 145 140
Measure Type: Number
Unit of Measure: participants
SVR12=YES 7 69 72 1 33 25 49 46
BL normal to EoT normal 2 35 39 0 13 10 15 16
BL elevated to EoT normal 4 24 22 1 10 9 21 20
No EoT data available for AST 1 0 0 0 0 1 1 0
8.Secondary Outcome
Title ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO
Hide Description The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame 12 weeks post treatment, up to 60 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Relapser:Placebo Relapser:Faldaprevir 12 Weeks Relapser:Faldaprevir 24 Weeks Partial:Placebo Partial:Faldaprevir 12 Weeks Partial:Faldaprevir 24 Weeks Null:Faldaprevir 12 Weeks Null:Faldaprevir 24 Weeks
Hide Arm/Group Description:
Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Overall Number of Participants Analyzed 49 99 103 29 57 55 145 140
Measure Type: Number
Unit of Measure: participants
SVR12=NO 42 30 31 28 24 30 96 94
BL normal to SVR12 normal 0 9 6 0 2 4 11 6
BL elevated to SVR12 normal 1 6 6 0 4 3 7 9
No ALT data available at SVR12 visit 33 7 3 23 6 5 27 30
9.Secondary Outcome
Title ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES
Hide Description The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame 12 weeks post treatment, up to 60 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Relapser:Placebo Relapser:Faldaprevir 12 Weeks Relapser:Faldaprevir 24 Weeks Partial:Placebo Partial:Faldaprevir 12 Weeks Partial:Faldaprevir 24 Weeks Null:Faldaprevir 12 Weeks Null:Faldaprevir 24 Weeks
Hide Arm/Group Description:
Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Overall Number of Participants Analyzed 49 99 103 29 57 55 145 140
Measure Type: Number
Unit of Measure: participants
SVR12=YES 7 69 72 1 33 25 49 46
BL normal to SVR12 normal 3 31 31 0 13 10 13 10
BL elevated to SVR12 normal 3 35 38 1 20 11 32 35
No ALT data available at SVR12 visit 1 1 0 0 0 0 1 0
10.Secondary Outcome
Title AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO
Hide Description The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame 12 weeks post treatment, up to 60 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Relapser:Placebo Relapser:Faldaprevir 12 Weeks Relapser:Faldaprevir 24 Weeks Partial:Placebo Partial:Faldaprevir 12 Weeks Partial:Faldaprevir 24 Weeks Null:Faldaprevir 12 Weeks Null:Faldaprevir 24 Weeks
Hide Arm/Group Description:
Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Overall Number of Participants Analyzed 49 99 103 29 57 55 145 140
Measure Type: Number
Unit of Measure: participants
SVR12=NO 42 30 31 28 24 30 96 94
BL normal to SVR12 normal 0 14 10 0 3 3 13 14
BL elevated to SVR12 normal 2 2 6 0 6 3 6 3
No AST data available at SVR12 visit 33 7 3 23 6 6 27 30
11.Secondary Outcome
Title AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES
Hide Description The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame 12 weeks post treatment, up to 60 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Relapser:Placebo Relapser:Faldaprevir 12 Weeks Relapser:Faldaprevir 24 Weeks Partial:Placebo Partial:Faldaprevir 12 Weeks Partial:Faldaprevir 24 Weeks Null:Faldaprevir 12 Weeks Null:Faldaprevir 24 Weeks
Hide Arm/Group Description:
Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
Overall Number of Participants Analyzed 49 99 103 29 57 55 145 140
Measure Type: Number
Unit of Measure: participants
SVR12=YES 7 69 72 1 33 25 49 46
BL normal to SVR12 normal 2 36 41 0 16 13 16 17
BL elevated to SVR12 normal 4 29 28 1 16 8 28 25
No AST data available at SVR12 visit 1 1 0 0 0 0 1 0
Time Frame During the course of the study (48 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Relapser & Partial: Placebo Relapser & Partial: Faldaprevir 12 Weeks Relapser & Partial: Faldaprevir 24 Weeks Null:Faldaprevir 12 Weeks Null:Faldaprevir 24 Weeks
Hide Arm/Group Description Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks. Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)). Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)). Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks. Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
All-Cause Mortality
Relapser & Partial: Placebo Relapser & Partial: Faldaprevir 12 Weeks Relapser & Partial: Faldaprevir 24 Weeks Null:Faldaprevir 12 Weeks Null:Faldaprevir 24 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Relapser & Partial: Placebo Relapser & Partial: Faldaprevir 12 Weeks Relapser & Partial: Faldaprevir 24 Weeks Null:Faldaprevir 12 Weeks Null:Faldaprevir 24 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/78 (1.28%)   14/156 (8.97%)   13/158 (8.23%)   16/145 (11.03%)   11/140 (7.86%) 
Blood and lymphatic system disorders           
Anaemia  1  0/78 (0.00%)  1/156 (0.64%)  1/158 (0.63%)  2/145 (1.38%)  1/140 (0.71%) 
Haemolytic anaemia  1  0/78 (0.00%)  1/156 (0.64%)  0/158 (0.00%)  0/145 (0.00%)  0/140 (0.00%) 
Leukopenia  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  1/145 (0.69%)  0/140 (0.00%) 
Thrombocytopenia  1  0/78 (0.00%)  0/156 (0.00%)  3/158 (1.90%)  0/145 (0.00%)  0/140 (0.00%) 
Cardiac disorders           
Atrial fibrillation  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  0/145 (0.00%)  1/140 (0.71%) 
Bradycardia  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  0/145 (0.00%)  0/140 (0.00%) 
Cardiac failure congestive  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  0/145 (0.00%)  1/140 (0.71%) 
Cardio-respiratory arrest  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  0/145 (0.00%)  0/140 (0.00%) 
Congenital, familial and genetic disorders           
Keratosis follicular  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  0/145 (0.00%)  1/140 (0.71%) 
Gastrointestinal disorders           
Abdominal pain  1  0/78 (0.00%)  1/156 (0.64%)  0/158 (0.00%)  0/145 (0.00%)  0/140 (0.00%) 
Ascites  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  2/145 (1.38%)  0/140 (0.00%) 
Diarrhoea  1  0/78 (0.00%)  1/156 (0.64%)  0/158 (0.00%)  2/145 (1.38%)  2/140 (1.43%) 
Haematochezia  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  1/145 (0.69%)  0/140 (0.00%) 
Nausea  1  0/78 (0.00%)  1/156 (0.64%)  1/158 (0.63%)  1/145 (0.69%)  0/140 (0.00%) 
Oral lichen planus  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  0/145 (0.00%)  0/140 (0.00%) 
Pancreatitis  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  1/145 (0.69%)  0/140 (0.00%) 
Pancreatitis acute  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  1/145 (0.69%)  0/140 (0.00%) 
Peritoneal haemorrhage  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  0/145 (0.00%)  0/140 (0.00%) 
Salivary gland calculus  1  0/78 (0.00%)  1/156 (0.64%)  0/158 (0.00%)  0/145 (0.00%)  0/140 (0.00%) 
Vomiting  1  0/78 (0.00%)  2/156 (1.28%)  0/158 (0.00%)  0/145 (0.00%)  0/140 (0.00%) 
General disorders           
Asthenia  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  0/145 (0.00%)  1/140 (0.71%) 
Chest pain  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  0/145 (0.00%)  0/140 (0.00%) 
Fatigue  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  0/145 (0.00%)  0/140 (0.00%) 
Malaise  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  1/145 (0.69%)  1/140 (0.71%) 
Pyrexia  1  0/78 (0.00%)  3/156 (1.92%)  1/158 (0.63%)  3/145 (2.07%)  1/140 (0.71%) 
Hepatobiliary disorders           
Biliary colic  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  1/145 (0.69%)  0/140 (0.00%) 
Cholelithiasis  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  1/145 (0.69%)  0/140 (0.00%) 
Hepatic failure  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  1/145 (0.69%)  0/140 (0.00%) 
Hepatorenal failure  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  0/145 (0.00%)  0/140 (0.00%) 
Hyperbilirubinaemia  1  0/78 (0.00%)  1/156 (0.64%)  0/158 (0.00%)  1/145 (0.69%)  0/140 (0.00%) 
Jaundice  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  1/145 (0.69%)  0/140 (0.00%) 
Infections and infestations           
Appendicitis  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  0/145 (0.00%)  1/140 (0.71%) 
Cellulitis  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  0/145 (0.00%)  0/140 (0.00%) 
Gastroenteritis  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  0/145 (0.00%)  1/140 (0.71%) 
Gastroenteritis viral  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  0/145 (0.00%)  1/140 (0.71%) 
Peritonitis bacterial  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  1/145 (0.69%)  0/140 (0.00%) 
Pneumonia  1  0/78 (0.00%)  1/156 (0.64%)  1/158 (0.63%)  0/145 (0.00%)  0/140 (0.00%) 
Sepsis  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  1/145 (0.69%)  0/140 (0.00%) 
Streptococcal infection  1  0/78 (0.00%)  1/156 (0.64%)  0/158 (0.00%)  0/145 (0.00%)  0/140 (0.00%) 
Viral infection  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  0/145 (0.00%)  0/140 (0.00%) 
Injury, poisoning and procedural complications           
Fall  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  0/145 (0.00%)  0/140 (0.00%) 
Multiple injuries  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  0/145 (0.00%)  0/140 (0.00%) 
Investigations           
Blood lactate dehydrogenase increased  1  0/78 (0.00%)  1/156 (0.64%)  0/158 (0.00%)  0/145 (0.00%)  0/140 (0.00%) 
International normalised ratio abnormal  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  1/145 (0.69%)  0/140 (0.00%) 
Metabolism and nutrition disorders           
Decreased appetite  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  0/145 (0.00%)  1/140 (0.71%) 
Dehydration  1  0/78 (0.00%)  1/156 (0.64%)  0/158 (0.00%)  0/145 (0.00%)  0/140 (0.00%) 
Hypoglycaemia  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  1/145 (0.69%)  0/140 (0.00%) 
Hypokalaemia  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  0/145 (0.00%)  0/140 (0.00%) 
Metabolic acidosis  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  0/145 (0.00%)  0/140 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  1/145 (0.69%)  0/140 (0.00%) 
Fasciitis  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  0/145 (0.00%)  0/140 (0.00%) 
Joint instability  1  0/78 (0.00%)  1/156 (0.64%)  0/158 (0.00%)  0/145 (0.00%)  0/140 (0.00%) 
Musculoskeletal discomfort  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  0/145 (0.00%)  1/140 (0.71%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Hepatocellular carcinoma  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  0/145 (0.00%)  1/140 (0.71%) 
Nervous system disorders           
Coma  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  0/145 (0.00%)  0/140 (0.00%) 
Headache  1  0/78 (0.00%)  1/156 (0.64%)  0/158 (0.00%)  1/145 (0.69%)  0/140 (0.00%) 
Presyncope  1  0/78 (0.00%)  1/156 (0.64%)  1/158 (0.63%)  0/145 (0.00%)  0/140 (0.00%) 
Psychiatric disorders           
Anxiety  1  0/78 (0.00%)  1/156 (0.64%)  0/158 (0.00%)  0/145 (0.00%)  0/140 (0.00%) 
Depression  1  1/78 (1.28%)  0/156 (0.00%)  0/158 (0.00%)  0/145 (0.00%)  0/140 (0.00%) 
Psychiatric decompensation  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  0/145 (0.00%)  0/140 (0.00%) 
Renal and urinary disorders           
Renal colic  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  0/145 (0.00%)  1/140 (0.71%) 
Respiratory, thoracic and mediastinal disorders           
Pleural effusion  1  1/78 (1.28%)  0/156 (0.00%)  0/158 (0.00%)  0/145 (0.00%)  0/140 (0.00%) 
Traumatic haemothorax  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  0/145 (0.00%)  0/140 (0.00%) 
Skin and subcutaneous tissue disorders           
Rash erythematous  1  0/78 (0.00%)  0/156 (0.00%)  0/158 (0.00%)  1/145 (0.69%)  0/140 (0.00%) 
Rash generalised  1  0/78 (0.00%)  1/156 (0.64%)  0/158 (0.00%)  0/145 (0.00%)  0/140 (0.00%) 
Vascular disorders           
Hypertensive crisis  1  0/78 (0.00%)  1/156 (0.64%)  0/158 (0.00%)  0/145 (0.00%)  0/140 (0.00%) 
Hypotension  1  0/78 (0.00%)  0/156 (0.00%)  1/158 (0.63%)  1/145 (0.69%)  0/140 (0.00%) 
Venous thrombosis  1  0/78 (0.00%)  1/156 (0.64%)  0/158 (0.00%)  0/145 (0.00%)  0/140 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Relapser & Partial: Placebo Relapser & Partial: Faldaprevir 12 Weeks Relapser & Partial: Faldaprevir 24 Weeks Null:Faldaprevir 12 Weeks Null:Faldaprevir 24 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   74/78 (94.87%)   148/156 (94.87%)   156/158 (98.73%)   142/145 (97.93%)   139/140 (99.29%) 
Blood and lymphatic system disorders           
Anaemia  1  8/78 (10.26%)  30/156 (19.23%)  27/158 (17.09%)  22/145 (15.17%)  19/140 (13.57%) 
Neutropenia  1  12/78 (15.38%)  18/156 (11.54%)  18/158 (11.39%)  16/145 (11.03%)  13/140 (9.29%) 
Thrombocytopenia  1  3/78 (3.85%)  4/156 (2.56%)  6/158 (3.80%)  13/145 (8.97%)  3/140 (2.14%) 
Ear and labyrinth disorders           
Vertigo  1  3/78 (3.85%)  4/156 (2.56%)  4/158 (2.53%)  6/145 (4.14%)  9/140 (6.43%) 
Eye disorders           
Dry eye  1  5/78 (6.41%)  6/156 (3.85%)  7/158 (4.43%)  4/145 (2.76%)  5/140 (3.57%) 
Ocular icterus  1  0/78 (0.00%)  8/156 (5.13%)  6/158 (3.80%)  6/145 (4.14%)  2/140 (1.43%) 
Gastrointestinal disorders           
Abdominal pain  1  2/78 (2.56%)  8/156 (5.13%)  14/158 (8.86%)  7/145 (4.83%)  13/140 (9.29%) 
Abdominal pain upper  1  4/78 (5.13%)  16/156 (10.26%)  15/158 (9.49%)  11/145 (7.59%)  15/140 (10.71%) 
Constipation  1  3/78 (3.85%)  14/156 (8.97%)  8/158 (5.06%)  7/145 (4.83%)  7/140 (5.00%) 
Diarrhoea  1  10/78 (12.82%)  45/156 (28.85%)  59/158 (37.34%)  39/145 (26.90%)  47/140 (33.57%) 
Dyspepsia  1  6/78 (7.69%)  13/156 (8.33%)  13/158 (8.23%)  12/145 (8.28%)  9/140 (6.43%) 
Gastrooesophageal reflux disease  1  5/78 (6.41%)  3/156 (1.92%)  0/158 (0.00%)  3/145 (2.07%)  6/140 (4.29%) 
Nausea  1  18/78 (23.08%)  78/156 (50.00%)  88/158 (55.70%)  77/145 (53.10%)  75/140 (53.57%) 
Vomiting  1  5/78 (6.41%)  41/156 (26.28%)  47/158 (29.75%)  46/145 (31.72%)  37/140 (26.43%) 
General disorders           
Asthenia  1  21/78 (26.92%)  28/156 (17.95%)  28/158 (17.72%)  24/145 (16.55%)  28/140 (20.00%) 
Chills  1  5/78 (6.41%)  9/156 (5.77%)  14/158 (8.86%)  1/145 (0.69%)  8/140 (5.71%) 
Fatigue  1  16/78 (20.51%)  53/156 (33.97%)  59/158 (37.34%)  45/145 (31.03%)  47/140 (33.57%) 
Influenza like illness  1  15/78 (19.23%)  28/156 (17.95%)  29/158 (18.35%)  27/145 (18.62%)  23/140 (16.43%) 
Injection site erythema  1  4/78 (5.13%)  1/156 (0.64%)  3/158 (1.90%)  4/145 (2.76%)  4/140 (2.86%) 
Malaise  1  4/78 (5.13%)  5/156 (3.21%)  10/158 (6.33%)  4/145 (2.76%)  11/140 (7.86%) 
Pain  1  4/78 (5.13%)  5/156 (3.21%)  7/158 (4.43%)  4/145 (2.76%)  4/140 (2.86%) 
Pyrexia  1  14/78 (17.95%)  24/156 (15.38%)  25/158 (15.82%)  26/145 (17.93%)  38/140 (27.14%) 
Hepatobiliary disorders           
Hyperbilirubinaemia  1  0/78 (0.00%)  11/156 (7.05%)  11/158 (6.96%)  10/145 (6.90%)  9/140 (6.43%) 
Jaundice  1  1/78 (1.28%)  29/156 (18.59%)  27/158 (17.09%)  16/145 (11.03%)  16/140 (11.43%) 
Infections and infestations           
Influenza  1  4/78 (5.13%)  4/156 (2.56%)  6/158 (3.80%)  4/145 (2.76%)  1/140 (0.71%) 
Nasopharyngitis  1  7/78 (8.97%)  14/156 (8.97%)  13/158 (8.23%)  6/145 (4.14%)  10/140 (7.14%) 
Investigations           
Haemoglobin decreased  1  2/78 (2.56%)  6/156 (3.85%)  4/158 (2.53%)  9/145 (6.21%)  10/140 (7.14%) 
Weight decreased  1  3/78 (3.85%)  7/156 (4.49%)  2/158 (1.27%)  8/145 (5.52%)  8/140 (5.71%) 
Metabolism and nutrition disorders           
Decreased appetite  1  10/78 (12.82%)  33/156 (21.15%)  32/158 (20.25%)  27/145 (18.62%)  36/140 (25.71%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  7/78 (8.97%)  14/156 (8.97%)  21/158 (13.29%)  10/145 (6.90%)  15/140 (10.71%) 
Back pain  1  8/78 (10.26%)  14/156 (8.97%)  12/158 (7.59%)  5/145 (3.45%)  7/140 (5.00%) 
Muscle spasms  1  2/78 (2.56%)  7/156 (4.49%)  8/158 (5.06%)  4/145 (2.76%)  8/140 (5.71%) 
Myalgia  1  8/78 (10.26%)  20/156 (12.82%)  19/158 (12.03%)  15/145 (10.34%)  18/140 (12.86%) 
Nervous system disorders           
Disturbance in attention  1  1/78 (1.28%)  4/156 (2.56%)  9/158 (5.70%)  2/145 (1.38%)  4/140 (2.86%) 
Dizziness  1  6/78 (7.69%)  12/156 (7.69%)  11/158 (6.96%)  9/145 (6.21%)  5/140 (3.57%) 
Dysgeusia  1  4/78 (5.13%)  8/156 (5.13%)  12/158 (7.59%)  7/145 (4.83%)  12/140 (8.57%) 
Headache  1  22/78 (28.21%)  39/156 (25.00%)  46/158 (29.11%)  52/145 (35.86%)  45/140 (32.14%) 
Psychiatric disorders           
Anxiety  1  3/78 (3.85%)  9/156 (5.77%)  12/158 (7.59%)  5/145 (3.45%)  11/140 (7.86%) 
Depression  1  10/78 (12.82%)  11/156 (7.05%)  12/158 (7.59%)  14/145 (9.66%)  15/140 (10.71%) 
Insomnia  1  13/78 (16.67%)  36/156 (23.08%)  35/158 (22.15%)  18/145 (12.41%)  29/140 (20.71%) 
Sleep disorder  1  3/78 (3.85%)  4/156 (2.56%)  5/158 (3.16%)  8/145 (5.52%)  10/140 (7.14%) 
Irritability  1  11/78 (14.10%)  10/156 (6.41%)  16/158 (10.13%)  10/145 (6.90%)  13/140 (9.29%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  16/78 (20.51%)  25/156 (16.03%)  27/158 (17.09%)  23/145 (15.86%)  24/140 (17.14%) 
Dyspnoea  1  7/78 (8.97%)  16/156 (10.26%)  16/158 (10.13%)  8/145 (5.52%)  7/140 (5.00%) 
Epistaxis  1  4/78 (5.13%)  5/156 (3.21%)  3/158 (1.90%)  4/145 (2.76%)  3/140 (2.14%) 
Skin and subcutaneous tissue disorders           
Alopecia  1  4/78 (5.13%)  16/156 (10.26%)  16/158 (10.13%)  8/145 (5.52%)  13/140 (9.29%) 
Dry skin  1  12/78 (15.38%)  29/156 (18.59%)  29/158 (18.35%)  19/145 (13.10%)  31/140 (22.14%) 
Erythema  1  4/78 (5.13%)  8/156 (5.13%)  9/158 (5.70%)  11/145 (7.59%)  12/140 (8.57%) 
Pruritus  1  23/78 (29.49%)  54/156 (34.62%)  61/158 (38.61%)  47/145 (32.41%)  63/140 (45.00%) 
Rash  1  16/78 (20.51%)  37/156 (23.72%)  44/158 (27.85%)  38/145 (26.21%)  41/140 (29.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 17.0
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
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01358864     History of Changes
Other Study ID Numbers: 1220.7
2010-021715-17 ( EudraCT Number: EudraCT )
First Submitted: May 23, 2011
First Posted: May 24, 2011
Results First Submitted: July 3, 2015
Results First Posted: October 28, 2015
Last Update Posted: August 29, 2016