Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 72 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)

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: NCT00984620
Recruitment Status : Completed
First Posted : September 25, 2009
Results First Posted : September 7, 2015
Last Update Posted : September 7, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: BI 201335
Drug: Pegylated Interferon-alpha (IFN)
Drug: Ribavirin (RBV)
Enrollment 160
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Faldaprevir 120mg (12 Weeks) Faldaprevir 120mg (24 Weeks)
Hide Arm/Group Description Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Period Title: Overall Study
Started 81 79
Completed 75 67
Not Completed 6 12
Reason Not Completed
Adverse Event             5             5
Lost to Follow-up             1             1
Withdrawal by Subject             0             2
reason other than listed above             0             4
Arm/Group Title Faldaprevir 120 mg (12 Weeks) Faldaprevir 120 mg (24 Weeks) Total
Hide Arm/Group Description Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 81 79 160
Hide Baseline Analysis Population Description
Full Analysis Set (FAS): contained all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 79 participants 160 participants
48.1  (9.4) 44.9  (11.9) 46.5  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 79 participants 160 participants
Female
27
  33.3%
34
  43.0%
61
  38.1%
Male
54
  66.7%
45
  57.0%
99
  61.9%
1.Primary Outcome
Title Virological Response at Week 28 (W28VR)
Hide Description Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28.
Time Frame 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set (PPS): included all patients in the FAS without important protocol deviations.
Arm/Group Title Faldaprevir 120 mg (12 Weeks) Faldaprevir 120 mg (24 Weeks)
Hide Arm/Group Description:
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Overall Number of Participants Analyzed 81 78
Measure Type: Number
Unit of Measure: participants
61 60
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Faldaprevir 120 mg (12 Weeks), Faldaprevir 120 mg (24 Weeks)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.855
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Based on an Cochran−Mantel−Haenszel method adjusted by HCV genotype (1a and 1b only).
Method of Estimation Estimation Parameter Adjusted percent difference
Estimated Value -1.25
Confidence Interval (2-Sided) 95%
-14.3 to 11.8
Estimation Comments p−value presented is 2−sided. The percent differences and p−values are based on a comparison to the Faldaprevir 120mg (12 Weeks).
2.Secondary Outcome
Title Rapid Virological Response at Week 4 (RVR)
Hide Description Rapid virological response at week 4 (RVR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 4.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
PPS
Arm/Group Title Faldaprevir 120 mg (12 Weeks) Faldaprevir 120 mg (24 Weeks)
Hide Arm/Group Description:
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Overall Number of Participants Analyzed 81 78
Measure Type: Number
Unit of Measure: participants
48 56
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Faldaprevir 120 mg (12 Weeks), Faldaprevir 120 mg (24 Weeks)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.229
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Based on an Cochran−Mantel−Haenszel method adjusted by HCV genotype (1a and 1b only).
Method of Estimation Estimation Parameter Adjusted percent difference
Estimated Value 9.02
Confidence Interval (2-Sided) 95%
-5.3 to 23.3
Estimation Comments p−value presented is 2−sided. The percent differences and p−values are based on a comparison to the Faldaprevir 120mg (12 Weeks).
3.Secondary Outcome
Title Virological Response at Week 24 (W24VR)
Hide Description virological response at week 24 (W24VR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 24.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
PPS
Arm/Group Title Faldaprevir 120 mg (12 Weeks) Faldaprevir 120 mg (24 Weeks)
Hide Arm/Group Description:
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Overall Number of Participants Analyzed 81 78
Measure Type: Number
Unit of Measure: participants
59 63
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Faldaprevir 120 mg (12 Weeks), Faldaprevir 120 mg (24 Weeks)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.417
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Based on an Cochran−Mantel−Haenszel method adjusted by HCV genotype (1a and 1b only).
Method of Estimation Estimation Parameter Adjusted percent difference
Estimated Value 5.48
Confidence Interval (2-Sided) 95%
-7.3 to 18.3
Estimation Comments p−value presented is 2−sided. The percent differences and p−values are based on a comparison to the Faldaprevir 120mg (12 Weeks).
4.Secondary Outcome
Title Virological Response at Week 36 (W36VR)
Hide Description Virological response at week 36 (W36VR): the patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 36.
Time Frame 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
PPS
Arm/Group Title Faldaprevir 120 mg (12 Weeks) Faldaprevir 120 mg (24 Weeks)
Hide Arm/Group Description:
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Overall Number of Participants Analyzed 81 78
Measure Type: Number
Unit of Measure: participants
55 58
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Faldaprevir 120 mg (12 Weeks), Faldaprevir 120 mg (24 Weeks)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.676
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Based on an Cochran−Mantel−Haenszel method adjusted by HCV genotype (1a and 1b only).
Method of Estimation Estimation Parameter Adjusted percent difference
Estimated Value 2.99
Confidence Interval (2-Sided) 95%
-10.6 to 16.6
Estimation Comments p−value presented is 2−sided. The percent differences and p−values are based on a comparison to the Faldaprevir 120mg (12 Weeks).
5.Secondary Outcome
Title End of Treatment Response (ETR)
Hide Description End of Treatment Response (ETR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at end of all therapy.
Time Frame up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
PPS
Arm/Group Title Faldaprevir 120 mg (12 Weeks) Faldaprevir 120 mg (24 Weeks)
Hide Arm/Group Description:
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Overall Number of Participants Analyzed 81 78
Measure Type: Number
Unit of Measure: participants
65 67
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Faldaprevir 120 mg (12 Weeks), Faldaprevir 120 mg (24 Weeks)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.588
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Based on an Cochran−Mantel−Haenszel method adjusted by HCV genotype (1a and 1b only).
Method of Estimation Estimation Parameter Adjusted percent difference
Estimated Value 3.24
Confidence Interval (2-Sided) 95%
-8.1 to 14.6
Estimation Comments p−value presented is 2−sided. The percent differences and p−values are based on a comparison to the Faldaprevir 120mg (12 Weeks).
6.Secondary Outcome
Title Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy
Hide Description Sustained Virological Response (SVR24) at 24 weeks: The patients who reached plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at 24 weeks after completion of all Hepatitis C virus (HCV) therapy.
Time Frame 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
PPS
Arm/Group Title Faldaprevir 120 mg (12 Weeks) Faldaprevir 120 mg (24 Weeks)
Hide Arm/Group Description:
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Overall Number of Participants Analyzed 81 78
Measure Type: Number
Unit of Measure: participants
54 58
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Faldaprevir 120 mg (12 Weeks), Faldaprevir 120 mg (24 Weeks)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.512
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Based on an Cochran−Mantel−Haenszel method adjusted by HCV genotype (1a and 1b only).
Method of Estimation Estimation Parameter Adjusted percent difference
Estimated Value 4.78
Confidence Interval (2-Sided) 95%
-9.0 to 18.6
Estimation Comments p−value presented is 2−sided. The percent differences and p−values are based on a comparison to the Faldaprevir 120mg (12 Weeks).
7.Secondary Outcome
Title Viral Load (HCV RNA) at All Visits During Treatment and Follow-up
Hide Description Viral load of Hepatitis C virus Ribonucleic acid (HCV RNA) at all visits during treatment (TRT) and follow-up, ie. change from baseline viral load at all visits.
Time Frame From baseline to 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
PPS
Arm/Group Title Faldaprevir 120 mg (12 Weeks) Faldaprevir 120 mg (24 Weeks)
Hide Arm/Group Description:
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Overall Number of Participants Analyzed 81 78
Mean (Standard Deviation)
Unit of Measure: IU/mL
week 2, change from baseline (N=76, N=78) -4.724  (0.9059) -4.866  (0.8664)
week 4, change from baseline (N=76, N=77) -4.993  (1.1168) -5.081  (1.1195)
week 8, change from baseline (N=75, N=76) -5.128  (1.1159) -5.088  (1.3150)
week 12, change from baseline (N=76, N=76) -5.117  (1.1495) -5.107  (1.2852)
week 16, change from baseline (N=18, N=13) -5.363  (1.2341) -5.262  (0.5820)
week 20, change from baseline (N=52, N=57) -5.056  (1.0894) -5.366  (0.7319)
week 24, change from baseline (N=12, N=8) -4.176  (2.1635) -4.740  (1.6576)
week 28, change from baseline (N=4, N=4) -5.723  (0.6795) -4.369  (2.2917)
week 36, change from baseline (N=4, N=2) -5.624  (0.7059) -5.958  (0.1909)
End of TRT, change from baseline (N=80, N=78) -4.910  (1.4690) -5.017  (1.4434)
4 wks after TRT, change from baseline (N=75, N=77) -4.296  (2.2499) -4.367  (2.1849)
12 wks after TRT, change from baseline (N=75,N=75) -4.154  (2.3356) -4.353  (2.1588)
24 wks after TRT, change from baseline (N=73,N=75) -4.103  (2.3673) -4.250  (2.2439)
8.Secondary Outcome
Title Time to Reach a Plasma HCV RNA Level BLD While on Treatment
Hide Description Time to reach a plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) level below the lower limit of detection (BLD) while on treatment
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
PPS
Arm/Group Title Faldaprevir 120 mg (12 Weeks) Faldaprevir 120 mg (24 Weeks)
Hide Arm/Group Description:
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Overall Number of Participants Analyzed 81 78
Median (Inter-Quartile Range)
Unit of Measure: week
4.1
(4 to 8)
4.1
(2 to 8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Faldaprevir 120 mg (12 Weeks), Faldaprevir 120 mg (24 Weeks)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1397
Comments Compare 120 MG Faldaprevir 120mg (24 Weeks) over 120 MG Faldaprevir 120mg (12 Weeks) using log−rank test.
Method Log Rank
Comments [Not Specified]
9.Secondary Outcome
Title Laboratory Test Abnormalities and Study Medication Tolerabilities
Hide Description Participants with possible clinically significant laboratory test abnormalities observed in functional groups: Haematology, Coagulation, Electrolytes, Enzymes, Substrates and Differentials, automatic.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Set (TS): comprised all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment regardless of randomisation.
Arm/Group Title Faldaprevir 120 mg (12 Weeks) Faldaprevir 120 mg (24 Weeks)
Hide Arm/Group Description:
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Overall Number of Participants Analyzed 81 79
Measure Type: Number
Unit of Measure: participants
Red blood cell count: low (N=81, N=79) 9 8
haematocrit: low (N=81, N=79) 30 21
haematocrit: high(N=81, N=79) 0 1
white blood cell count: low(N=81, N=79) 56 60
platelets: low(N=81, N=78) 5 2
eosinophils: high (N=81, N=79) 1 5
PT-INR: high (N=81, N=79) 1 1
sodium: low (N=81, N=79) 1 1
bicarbonate: low (N=79, N=74) 6 11
bicarbonate: high (N=79, N=74) 1 1
AST/GOT, SGOT: high (N=75, N=71) 3 3
ALT/GPT, SGPT: high (N=68, N=64) 3 5
alkaline phosphatase: high (N=80, N=79) 1 0
GGT: high (N=74, N=72) 4 8
creatine kinase: high (N=80, N=79) 0 3
lipase: high (N=79, N=79) 1 3
amylase: high (N=81, N=79) 1 2
glucose: low (N=80, N=79) 0 2
cholesterol, total: high (N=80, N=75) 6 2
triglyceride: high (N=74, N=71) 13 18
10.Secondary Outcome
Title Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination
Hide Description No number of participants with clinically relevant abnormalities in vital signs and physical examination.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Faldaprevir 120mg (12 Weeks) Faldaprevir 120mg (24 Weeks)
Hide Arm/Group Description:
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Overall Number of Participants Analyzed 81 79
Measure Type: Number
Unit of Measure: participants with abnormality
0 0
11.Secondary Outcome
Title Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)
Hide Description Change from baseline (CFB) in Red blood cells.
Time Frame baseline and 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Faldaprevir 120mg (12 Weeks) Faldaprevir 120mg (24 Weeks)
Hide Arm/Group Description:
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Overall Number of Participants Analyzed 81 79
Mean (Standard Deviation)
Unit of Measure: 10^12 cells/L
Red blood cell (10^12cells/L) CFB,Day 1(N=77,N=75) 0.0  (0.3) -0.1  (0.3)
Red blood cell (10^12cells/L) CFB, wk2 (N=75,N=77) -0.3  (0.5) -0.4  (0.5)
Red blood cell (10^12cells/L) CFB, wk4(N=74, N=76) -0.8  (0.5) -0.8  (0.6)
Red blood cell (10^12cells/L) CFB, wk8(N=75, N=74) -1.0  (0.5) -1.0  (0.5)
Red blood cell (10^12cells/L) CFB, wk12(N=74,N=74) -1.1  (0.6) -1.2  (0.5)
Red blood cell (10^12cells/L) CFB, wk18(N=66,N=69) -1.2  (0.6) -1.2  (0.5)
Red blood cell (10^12cells/L) CFB, wk24(N=12, N=4) -1.2  (0.7) -0.9  (0.4)
Red blood cell (10^12cells/L) CFB, wk28(N=4, N=3) -1.1  (0.4) -0.9  (0.7)
Red blood cell (10^12cells/L) CFB, wk36(N=4, N=2) -0.9  (0.9) -1.4  (0.2)
Red blood cell (10^12cells/L) CFB, EoT(N=67, N=73) -1.2  (0.6) -1.2  (0.5)
12.Secondary Outcome
Title Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)
Hide Description Change from baseline (CFB) in haematocrit and Eosinophils.
Time Frame baseline and 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Faldaprevir 120mg (12 Weeks) Faldaprevir 120mg (24 Weeks)
Hide Arm/Group Description:
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Overall Number of Participants Analyzed 81 79
Mean (Standard Deviation)
Unit of Measure: % of laboratory test substance
haematocrit (%) CFB, Day1 (N=77, N=75) -0.9  (3.0) -1.3  (2.7)
haematocrit (%) CFB, wk2 (N=75, N=77) -4.3  (4.4) -4.7  (4.2)
haematocrit (%) CFB, wk4 (N=74, N=76) -8.0  (4.9) -7.9  (4.5)
haematocrit (%) CFB, wk8 (N=75, N=74) -8.4  (4.6) -7.1  (4.0)
haematocrit (%) CFB, wk12 (N=72, N=74) -8.5  (4.9) -7.8  (3.9)
haematocrit (%) CFB, wk18 (N=66, N=69) -7.3  (5.4) -6.5  (4.4)
haematocrit (%) CFB, wk24 (N=11, N=4) -6.6  (6.2) -2.7  (2.4)
haematocrit (%) CFB, wk28 (N=4, N=3) -3.8  (3.9) -1.2  (4.4)
haematocrit (%) CFB, wk36 (N=4, N=2) -3.0  (8.0) -3.6  (0.0)
haematocrit (%) CFB, EoT (N=66, N=70) -6.0  (4.7) -6.0  (4.6)
Eosinophils(%), CFB, day1 (N=77, N=75) 0  (1) 0  (1)
Eosinophils(%), CFB, wk2 (N=75, N=76) 0  (2) 0  (1)
Eosinophils(%), CFB, wk4 (N=73, N=74) -1  (1) 0  (2)
Eosinophils(%), CFB, wk8 (N=74, N=73) 0  (2) 0  (5)
Eosinophils(%), CFB, wk12 (N=72, N=72) 0  (2) 0  (3)
Eosinophils(%), CFB, wk18 (N=62, N=65) 0  (3) 0  (2)
Eosinophils(%), CFB, wk24 (N=12, N=4) -1  (1) -1  (2)
Eosinophils(%), CFB, wk28 (N=4, N=3) -1  (1) -2  (2)
Eosinophils(%), CFB, wk36 (N=4, N=2) -1  (1) -1  (0)
Eosinophils(%), CFB, EoT (N=66, N=70) 0  (2) 1  (5)
13.Secondary Outcome
Title Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)
Hide Description Change from baseline (CFB) in Platelets and white blood cells.
Time Frame baseline and 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Faldaprevir 120mg (12 Weeks) Faldaprevir 120mg (24 Weeks)
Hide Arm/Group Description:
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Overall Number of Participants Analyzed 81 79
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
Platelets CFB, Day 1 (N=77, N=73) 3  (35) 2  (29)
Platelets CFB, wk2 (N=74, N=74) -35  (40) -35  (34)
Platelets CFB, wk4 (N=73, N=74) -35  (41) -39  (42)
Platelets CFB, wk8 (N=73, N=71) -55  (37) -48  (38)
Platelets CFB, wk12 (N=72, N=72) -61  (38) -50  (40)
Platelets CFB, wk18 (N=66, N=68) -55  (46) -51  (45)
Platelets CFB, wk24 (N=12, N=3) -46  (37) -50  (43)
Platelets CFB, wk28 (N=4, N=2) -22  (77) -83  (6)
Platelets CFB, wk36 (N=4, N=2) -47  (31) -85  (2)
Platelets CFB, EoT (N=67, N=71) -59  (46) -50  (48)
white blood cell CFB, day1 (N=77, N=75) -0.1  (1.1) 0.3  (1.3)
white blood cell CFB, wk2 (N=75, N=77) -2.2  (1.5) -1.8  (1.9)
white blood cell CFB, wk4 (N=74, N=76) -2.6  (1.5) -2.6  (1.9)
white blood cell CFB, wk8 (N=75, N=74) -3.2  (1.5) -2.9  (1.4)
white blood cell CFB, wk12 (N=74, N=74) -3.4  (1.5) -2.8  (1.8)
white blood cell CFB, wk18 (N=66, N=69) -3.2  (1.4) -3.1  (1.6)
white blood cell CFB, wk24 (N=12, N=4) -4.0  (1.3) -2.0  (1.7)
white blood cell CFB, wk28 (N=4, N=3) -2.8  (1.0) -1.9  (2.0)
white blood cell CFB, wk36 (N=4, N=2) -2.5  (0.9) -3.0  (1.1)
white blood cell CFB, EoT (N=67, N=73) -3.4  (1.5) -3.1  (1.6)
14.Secondary Outcome
Title Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)
Hide Description Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose.
Time Frame baseline and 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Faldaprevir 120mg (12 Weeks) Faldaprevir 120mg (24 Weeks)
Hide Arm/Group Description:
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Overall Number of Participants Analyzed 81 79
Mean (Standard Deviation)
Unit of Measure: mmol/L
Sodium (mmol/L) CFB, Day 1(N=77, N=74) 0  (2) 1  (2)
Sodium (mmol/L) CFB, wk2 (N=76, N=78) 0  (2) 0  (2)
Sodium (mmol/L) CFB, wk4 (N=76, N=77) 0  (2) 0  (2)
Sodium (mmol/L) CFB, wk8 (N=73, N=76) 1  (3) 1  (2)
Sodium (mmol/L) CFB, wk12 (N=75, N=76) 0  (2) 1  (2)
Sodium (mmol/L) CFB, wk18 (N=68, N=70) 0  (2) 0  (2)
Sodium (mmol/L) CFB, wk24 (N=12, N=4) -1  (2) 0  (1)
Sodium (mmol/L) CFB, wk28 (N=5, N=3) -2  (2) -1  (3)
Sodium (mmol/L) CFB, wk36 (N=4, N=2) -1  (2) -1  (2)
Sodium (mmol/L) CFB, EoT (N=67, N=73) 0  (2) 0  (3)
Bicarbonate (mmol/L), CFB, day1 (N=76, N=75) 0.1  (1.4) 0.2  (1.3)
Bicarbonate (mmol/L), CFB, wk2 (N=75, N=78) -0.2  (1.4) 0.0  (1.3)
Bicarbonate (mmol/L), CFB, wk4 (N=74, N=77) -0.1  (1.3) -0.1  (1.3)
Bicarbonate (mmol/L), CFB, wk8 (N=74, N=76) -0.1  (1.3) 0.0  (1.4)
Bicarbonate (mmol/L), CFB, wk12 (N=74, N=76) -0.3  (1.2) -0.4  (1.5)
Bicarbonate (mmol/L), CFB, wk18 (N=66, N=69) -0.3  (1.6) -0.4  (1.3)
Bicarbonate (mmol/L), CFB, wk24 (N=12, N=4) -0.4  (1.4) -0.5  (1.9)
Bicarbonate (mmol/L), CFB, wk28 (N=4, N=3) -1.2  (2.1) -0.2  (0.9)
Bicarbonate (mmol/L), CFB, wk36 (N=4, N=2) -2.6  (2.3) -1.0  (0.7)
Bicarbonate (mmol/L), CFB, EoT (N=64, N=71) -0.2  (1.6) -0.1  (1.4)
Cholesterol tot. (mmol/L), CFB, day1 (n=77, N=75) 0.03  (0.47) -0.05  (0.48)
Cholesterol tot. (mmol/L), CFB, wk2 (n=76, N=78) -0.48  (0.57) -0.54  (0.57)
Cholesterol tot. (mmol/L), CFB, wk4 (n=76, N=77) -0.51  (0.55) -0.67  (0.68)
Cholesterol tot. (mmol/L), CFB, wk8 (n=75, N=76) -0.58  (0.59) -0.60  (0.62)
Cholesterol tot. (mmol/L), CFB, wk12 (n=75, N=76) -0.64  (0.62) -0.74  (0.63)
Cholesterol tot. (mmol/L), CFB, wk18 (n=68, N=70) -0.51  (0.64) -0.80  (0.69)
Cholesterol tot. (mmol/L), CFB, wk24 (n=12, N=4) -0.36  (0.46) -0.37  (0.30)
Cholesterol tot. (mmol/L), CFB, wk28 (n=5, N=3) 0.10  (0.53) -0.09  (0.20)
Cholesterol tot. (mmol/L), CFB, wk36 (n=4, N=2) -0.35  (0.14) -0.23  (0.20)
Cholesterol tot. (mmol/L), CFB, EoT (n=67, N=73) -0.43  (0.70) -0.74  (0.68)
Triglyceride (mmol/L), CFB, day1 (N=77, N=75) -0.1  (0.5) -0.1  (0.3)
Triglyceride (mmol/L), CFB, wk2 (N=76, N=78) 0.1  (0.5) 0.1  (0.4)
Triglyceride (mmol/L), CFB, wk4 (N=76, N=77) 0.1  (0.5) 0.2  (0.6)
Triglyceride (mmol/L), CFB, wk8 (N=75, N=76) 0.1  (0.5) 0.1  (0.4)
Triglyceride (mmol/L), CFB, wk12 (N=75, N=76) 0.1  (0.6) 0.1  (0.5)
Triglyceride (mmol/L), CFB, wk18 (N=68, N=70) 0.0  (0.5) 0.2  (0.5)
Triglyceride (mmol/L), CFB, wk24 (N=12, N=4) -0.2  (0.7) 0.2  (0.3)
Triglyceride (mmol/L), CFB, wk28 (N=5, N=3) 0.0  (1.3) 0.4  (0.4)
Triglyceride (mmol/L), CFB, wk36 (N=4, N=2) -0.3  (0.7) 0.1  (0.5)
Triglyceride (mmol/L), CFB, EoT (N=67, N=73) 0.1  (0.6) 0.1  (0.6)
Glucose (mmol/L), CFB, day1 (N=76, N=75) -0.1  (1.3) 0.2  (0.9)
Glucose (mmol/L), CFB, wk2 (N=75, N=78) -0.1  (1.3) 0.1  (1.0)
Glucose (mmol/L), CFB, wk4 (N=74, N=77) -0.2  (1.3) 0.1  (0.9)
Glucose (mmol/L), CFB, wk8 (N=74, N=76) -0.1  (1.3) 0.1  (0.9)
Glucose (mmol/L), CFB, wk12 (N=73, N=76) -0.3  (1.1) -0.1  (1.0)
Glucose (mmol/L), CFB, wk18 (N=67, N=70) -0.4  (1.2) -0.1  (0.7)
Glucose (mmol/L), CFB, wk24 (N=12, N=4) -0.7  (1.3) -0.4  (0.7)
Glucose (mmol/L), CFB, wk28 (N=5, N=3) -0.4  (1.1) 0.1  (0.7)
Glucose (mmol/L), CFB, wk36 (N=4, N=2) -0.1  (0.7) -0.1  (0.4)
Glucose (mmol/L), CFB, EoT (N=66, N=71) -0.4  (1.2) -0.1  (1.3)
15.Secondary Outcome
Title Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)
Hide Description Change from baseline (CFB) in AST/GOT, ALT/GPT, Alka. phosphatase, GGT, Creatine kinase, Lipase, and Amylase.
Time Frame baseline and 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Faldaprevir 120mg (12 Weeks) Faldaprevir 120mg (24 Weeks)
Hide Arm/Group Description:
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Overall Number of Participants Analyzed 81 79
Mean (Standard Deviation)
Unit of Measure: U/L
AST/GOT (U/L), CFB, Day 1(N=74, N=75) 0  (28) -5  (29)
AST/GOT (U/L), CFB, wk2 (N=75, N=78) -24  (30) -29  (43)
AST/GOT (U/L), CFB, wk4 (N=74, N=76) -25  (31) -29  (49)
AST/GOT (U/L), CFB, wk8 (N=74, N=76) -22  (36) -27  (47)
AST/GOT (U/L), CFB, wk12 (N=74, N=76) -24  (29) -27  (44)
AST/GOT (U/L), CFB, wk18 (N=67, N=70) -25  (33) -30  (50)
AST/GOT (U/L), CFB, wk24 (N=12, N=4) -23  (60) -10  (15)
AST/GOT (U/L), CFB, wk28 (N=5, N=3) -20  (27) -16  (24)
AST/GOT (U/L), CFB, wk36 (N=4, N=2) -21  (40) 11  (4)
AST/GOT (U/L), CFB, EoT (N=66, N=71) -25  (41) -27  (49)
ALT/GPT (U/L), CFB, day1 (N=76, N=75) 1  (24) -2  (22)
ALT/GPT (U/L), CFB, wk2 (N=75, N=78) -37  (36) -34  (40)
ALT/GPT (U/L), CFB, wk4 (N=74, N=77) -37  (40) -34  (50)
ALT/GPT (U/L), CFB, wk8 (N=74, N=76) -36  (43) -35  (49)
ALT/GPT (U/L), CFB, wk12 (N=74, N=76) -37  (36) -36  (48)
ALT/GPT (U/L), CFB, wk18 (N=67, N=70) -41  (40) -42  (52)
ALT/GPT (U/L), CFB, wk24 (N=12, N=4) -40  (50) -24  (22)
ALT/GPT (U/L), CFB, wk28 (N=5, N=3) -45  (38) -22  (15)
ALT/GPT (U/L), CFB, wk36 (N=4, N=2) -47  (46) -6  (4)
ALT/GPT (U/L), CFB, EoT (N=66, N=71) -42  (42) -42  (45)
Alka. phosphatase (U/L), CFB, day1 (n=77, N=75) 1  (11) 1  (13)
Alka. phosphatase (U/L), CFB, wk2 (n=76, N=78) 5  (10) 7  (11)
Alka. phosphatase (U/L), CFB, wk4 (n=76, N=77) 7  (13) 10  (13)
Alka. phosphatase (U/L), CFB, wk8 (n=75, N=76) 7  (13) 9  (15)
Alka. phosphatase (U/L), CFB, wk12 (n=75, N=76) 5  (14) 6  (14)
Alka. phosphatase (U/L), CFB, wk18 (n=68, N=70) -2  (20) 5  (14)
Alka. phosphatase (U/L), CFB, wk24 (n=12, N=4) -14  (24) 13  (13)
Alka. phosphatase (U/L), CFB, wk28 (n=5, N=3) -2  (14) 15  (3)
Alka. phosphatase (U/L), CFB, wk36 (n=4, N=2) -5  (16) 18  (4)
Alka. phosphatase (U/L), CFB, EoT (n=67, N=73) 1  (22) 5  (16)
GGT (U/L), CFB, day1 (N=77, N=75) -5  (39) -5  (88)
GGT (U/L), CFB, wk2 (N=76, N=78) -34  (71) -38  (117)
GGT (U/L), CFB, wk4 (N=76, N=77) -59  (86) -60  (135)
GGT (U/L), CFB, wk8 (N=75, N=76) -76  (96) -70  (143)
GGT (U/L), CFB, wk12 (N=75, N=76) -71  (103) -69  (150)
GGT (U/L), CFB, wk18 (N=68, N=70) -62  (105) -64  (146)
GGT (U/L), CFB, wk24 (N=12, N=4) -118  (200) -131  (50)
GGT (U/L), CFB, wk28 (N=5, N=3) -52  (126) -113  (42)
GGT (U/L), CFB, wk36 (N=4, N=2) -23  (132) -14  (73)
GGT (U/L), CFB, EoT (N=67, N=73) -39  (106) -59  (148)
Creatine kinase (U/L), CFB, day1 (N=76, N=75) -2  (140) 30  (308)
Creatine kinase (U/L), CFB, wk2 (N=75, N=78) -59  (158) -41  (118)
Creatine kinase (U/L), CFB, wk4 (N=74, N=77) -69  (173) -62  (134)
Creatine kinase (U/L), CFB, wk8 (N=74, N=76) -92  (176) -75  (131)
Creatine kinase (U/L), CFB, wk12 (N=74, N=75) -98  (186) -84  (132)
Creatine kinase (U/L), CFB, wk18 (N=67, N=70) -93  (202) -60  (216)
Creatine kinase (U/L), CFB, wk24 (N=12, N=4) -69  (78) -42  (30)
Creatine kinase (U/L), CFB, wk28 (N=5, N=3) -48  (75) -32  (26)
Creatine kinase (U/L), CFB, wk36 (N=4, N=2) -68  (83) -37  (22)
Creatine kinase (U/L), CFB, EoT (N=66, N=71) -89  (187) -21  (331)
Lipase (U/L). CFB, day1 (N=77, N=75) -2  (52) 26  (239)
Lipase (U/L). CFB, wk2 (N=76, N=78) 5  (65) 9  (30)
Lipase (U/L). CFB, wk4 (N=76, N=76) -1  (52) 6  (36)
Lipase (U/L). CFB, wk8 (N=75, N=76) -11  (69) 2  (57)
Lipase (U/L). CFB, wk12 (N=75, N=75) -12  (70) 4  (90)
Lipase (U/L). CFB, wk18 (N=68, N=70) -13  (64) -4  (32)
Lipase (U/L). CFB, wk24 (N=12, N=4) 2  (31) -17  (22)
Lipase (U/L). CFB, wk28 (N=5, N=3) -1  (13) 0  (11)
Lipase (U/L). CFB, wk36 (N=4, N=2) -4  (12) -15  (0)
Lipase (U/L). CFB, EoT (N=67, N=73) -6  (82) -5  (27)
Amylase (U/L), CFB, day1 (N=77, N=75) 1  (26) 7  (68)
Amylase (U/L), CFB, wk2 (N=76, N=78) 5  (41) 3  (23)
Amylase (U/L), CFB, wk4 (N=76, N=77) 2  (30) 5  (27)
Amylase (U/L), CFB, wk8 (N=75, N=76) -5  (33) -2  (29)
Amylase (U/L), CFB, wk12 (N=75, N=75) -10  (33) -4  (33)
Amylase (U/L), CFB, wk18 (N=68, N=70) -7  (34) -7  (28)
Amylase (U/L), CFB, wk24 (N=12, N=4) -14  (35) -16  (23)
Amylase (U/L), CFB, wk28 (N=5, N=3) -21  (34) -8  (7)
Amylase (U/L), CFB, wk36 (N=4, N=2) -35  (24) -19  (9)
Amylase (U/L), CFB, EoT (N=67, N=73) 0  (37) -4  (27)
16.Secondary Outcome
Title Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)
Hide Description Change from baseline (CFB) in PT-INR (ratio).
Time Frame baseline and 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Faldaprevir 120mg (12 Weeks) Faldaprevir 120mg (24 Weeks)
Hide Arm/Group Description:
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Overall Number of Participants Analyzed 81 79
Mean (Standard Deviation)
Unit of Measure: ratio
PT-INR (ratio), CFB, Day 1(N=77, N=72) 0.0  (0.2) 0.0  (0.1)
PT-INR (ratio), CFB, wk2 (N=76, N=78) 0.0  (0.1) 0.0  (0.1)
PT-INR (ratio), CFB, wk4(N=74, N=76) 0.0  (0.1) 0.0  (0.1)
PT-INR (ratio), CFB, wk8(N=73, N=75) 0.0  (0.1) 0.0  (0.1)
PT-INR (ratio), CFB, wk12(N=74, N=72) 0.0  (0.1) 0.0  (0.1)
PT-INR (ratio), CFB, wk18(N=69, N=70) 0.0  (0.1) 0.0  (0.1)
PT-INR (ratio), CFB, wk24(N=12, N=4) 0.0  (0.1) 0.1  (0.1)
PT-INR (ratio), CFB, wk28(N=5, N=3) -0.1  (0.1) 0.0  (0.1)
PT-INR (ratio), CFB, wk36(N=4, N=2) 0.0  (0.1) -0.1  (0.1)
PT-INR (ratio), CFB, EoT(N=68, N=73) 0.0  (0.1) 0.0  (0.1)
Time Frame up to 24 weeks + 30 days washout.
Adverse Event Reporting Description One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
 
Arm/Group Title Faldaprevir 120 mg (12 Weeks) Faldaprevir 120 mg (24 Weeks)
Hide Arm/Group Description Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV).
All-Cause Mortality
Faldaprevir 120 mg (12 Weeks) Faldaprevir 120 mg (24 Weeks)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Faldaprevir 120 mg (12 Weeks) Faldaprevir 120 mg (24 Weeks)
Affected / at Risk (%) Affected / at Risk (%)
Total   3/80 (3.75%)   3/79 (3.80%) 
Blood and lymphatic system disorders     
Anaemia  1  2/80 (2.50%)  1/79 (1.27%) 
Neutropenia  1  0/80 (0.00%)  1/79 (1.27%) 
Infections and infestations     
Sepsis  1  1/80 (1.25%)  0/79 (0.00%) 
Nervous system disorders     
Epilepsy  1  0/80 (0.00%)  1/79 (1.27%) 
Psychiatric disorders     
Depression  1  1/80 (1.25%)  0/79 (0.00%) 
Renal and urinary disorders     
Renal failure  1  1/80 (1.25%)  0/79 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Interstitial lung disease  1  1/80 (1.25%)  0/79 (0.00%) 
Skin and subcutaneous tissue disorders     
Erythema  1  0/80 (0.00%)  1/79 (1.27%) 
Vascular disorders     
Hypotension  1  1/80 (1.25%)  0/79 (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%
Faldaprevir 120 mg (12 Weeks) Faldaprevir 120 mg (24 Weeks)
Affected / at Risk (%) Affected / at Risk (%)
Total   73/80 (91.25%)   68/79 (86.08%) 
Blood and lymphatic system disorders     
Anaemia  1  6/80 (7.50%)  13/79 (16.46%) 
Neutropenia  1  3/80 (3.75%)  7/79 (8.86%) 
Ear and labyrinth disorders     
Vertigo  1  5/80 (6.25%)  0/79 (0.00%) 
Eye disorders     
Dry eye  1  2/80 (2.50%)  4/79 (5.06%) 
Gastrointestinal disorders     
Abdominal pain  1  4/80 (5.00%)  5/79 (6.33%) 
Abdominal pain upper  1  4/80 (5.00%)  4/79 (5.06%) 
Constipation  1  4/80 (5.00%)  4/79 (5.06%) 
Diarrhoea  1  4/80 (5.00%)  15/79 (18.99%) 
Dry mouth  1  7/80 (8.75%)  2/79 (2.53%) 
Nausea  1  27/80 (33.75%)  17/79 (21.52%) 
Vomiting  1  11/80 (13.75%)  7/79 (8.86%) 
General disorders     
Asthenia  1  18/80 (22.50%)  13/79 (16.46%) 
Fatigue  1  17/80 (21.25%)  13/79 (16.46%) 
Influenza like illness  1  5/80 (6.25%)  7/79 (8.86%) 
Irritability  1  4/80 (5.00%)  7/79 (8.86%) 
Hepatobiliary disorders     
Jaundice  1  3/80 (3.75%)  4/79 (5.06%) 
Infections and infestations     
Bronchitis  1  2/80 (2.50%)  5/79 (6.33%) 
Metabolism and nutrition disorders     
Decreased appetite  1  14/80 (17.50%)  13/79 (16.46%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  6/80 (7.50%)  9/79 (11.39%) 
Back pain  1  7/80 (8.75%)  3/79 (3.80%) 
Myalgia  1  5/80 (6.25%)  4/79 (5.06%) 
Nervous system disorders     
Disturbance in attention  1  3/80 (3.75%)  6/79 (7.59%) 
Dizziness  1  4/80 (5.00%)  4/79 (5.06%) 
Headache  1  14/80 (17.50%)  18/79 (22.78%) 
Psychiatric disorders     
Anxiety  1  3/80 (3.75%)  7/79 (8.86%) 
Depression  1  7/80 (8.75%)  13/79 (16.46%) 
Insomnia  1  9/80 (11.25%)  15/79 (18.99%) 
Sleep disorder  1  3/80 (3.75%)  5/79 (6.33%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  13/80 (16.25%)  8/79 (10.13%) 
Dyspnoea  1  9/80 (11.25%)  6/79 (7.59%) 
Epistaxis  1  2/80 (2.50%)  4/79 (5.06%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  4/80 (5.00%)  13/79 (16.46%) 
Dry skin  1  12/80 (15.00%)  16/79 (20.25%) 
Eczema  1  3/80 (3.75%)  5/79 (6.33%) 
Pruritus  1  24/80 (30.00%)  26/79 (32.91%) 
Rash  1  18/80 (22.50%)  17/79 (21.52%) 
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: NCT00984620     History of Changes
Other Study ID Numbers: 1220.40
2009-012579-90 ( EudraCT Number: EudraCT )
First Submitted: September 24, 2009
First Posted: September 25, 2009
Results First Submitted: July 3, 2015
Results First Posted: September 7, 2015
Last Update Posted: September 7, 2015