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Trial record 13 of 16 for:    IU/mL | BI 201335 OR faldaprevir

Japanese Pegylated Interferon (PegIFN) Alfa-2b/Ribavirin (RBV) Combination Trial

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ClinicalTrials.gov Identifier: NCT01579474
Recruitment Status : Completed
First Posted : April 18, 2012
Results First Posted : August 3, 2015
Last Update Posted : August 3, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: BI 201335 high dose
Drug: BI 201335 low dose
Enrollment 131
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Faldaprevir 120 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort I Relapser Patients - Cohort II Partial Responder Patients - Cohort II Null Responder Patients - Cohort II Breakthrough Patients - Cohort II
Hide Arm/Group Description Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily (q.d.) for 12 or 24 weeks combined with pegylated interferon alfa-2b and ribavirin (PegIFNα-2b/RBV) for 24 weeks in treatment-naive patients. Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients. Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
Period Title: Overall Study
Started 44 43 29 3 10 2
Completed 41 30 27 3 9 1
Not Completed 3 13 2 0 1 1
Reason Not Completed
Adverse Event             1             13             2             0             0             1
Lack of Efficacy             1             0             0             0             1             0
Withdrawal by Subject             1             0             0             0             0             0
Arm/Group Title Faldaprevir 120 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort I Relapser Patients - Cohort II Partial Responder Patients - Cohort II Null Responder Patients - Cohort II Breakthrough Patients - Cohort II Total
Hide Arm/Group Description Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients. Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. Total of all reporting groups
Overall Number of Baseline Participants 44 43 29 3 10 2 131
Hide Baseline Analysis Population Description
FAS (All patients who were randomized and received at least 1 dose of the trial medication)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 43 participants 29 participants 3 participants 10 participants 2 participants 131 participants
53.5  (7.61) 56.6  (9.3) 61.3  (6.79) 47.0  (18.08) 54.9  (9.55) 57.5  (14.85) 56.3  (8.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 43 participants 29 participants 3 participants 10 participants 2 participants 131 participants
Female
22
  50.0%
27
  62.8%
14
  48.3%
2
  66.7%
5
  50.0%
2
 100.0%
72
  55.0%
Male
22
  50.0%
16
  37.2%
15
  51.7%
1
  33.3%
5
  50.0%
0
   0.0%
59
  45.0%
1.Primary Outcome
Title Number of Patients With Investigator Defined Drug-related Adverse Events
Hide Description Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analyses were based on the safety analysis set (SAF) that included all patients who took the trial medication and were documented to have taken at least 1 dose of the trial medication.
Arm/Group Title Faldaprevir 120 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort II
Hide Arm/Group Description:
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
Overall Number of Participants Analyzed 44 43 44
Measure Type: Number
Unit of Measure: participants
43 43 44
2.Secondary Outcome
Title Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT)
Hide Description Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration
Time Frame EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (All patients who were randomized and received at least 1 dose of the trial medication)
Arm/Group Title Faldaprevir 120 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort I Relapser Patients - Cohort II Partial Responder Patients - Cohort II Null Responder Patients - Cohort II Breakthrough Patients - Cohort II
Hide Arm/Group Description:
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined withPegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
Overall Number of Participants Analyzed 44 43 29 3 10 2
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
86.4
(76.2 to 96.5)
74.4
(61.4 to 87.5)
86.2
(73.7 to 98.8)
66.7
(13.3 to 100.0)
40.0
(9.6 to 70.4)
50.0
(0.0 to 100.0)
3.Secondary Outcome
Title Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT)
Hide Description Plasma HCV RNA level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration
Time Frame EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (All patients who were randomized and received at least 1 dose of the trial medication)
Arm/Group Title Faldaprevir 120 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort I Relapser Patients - Cohort II Partial Responder Patients - Cohort II Null Responder Patients - Cohort II Breakthrough Patients - Cohort II
Hide Arm/Group Description:
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
Overall Number of Participants Analyzed 44 43 29 3 10 2
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
86.4
(76.2 to 96.5)
72.1
(58.7 to 85.5)
86.2
(73.7 to 98.8)
66.7
(13.3 to 100.0)
40.0
(9.6 to 70.4)
50.0
(0.0 to 100.0)
4.Secondary Outcome
Title Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8
Hide Description Plasma HCV RNA level <25 IU/mL (detected or undetected) at Week 4 and HCV RNA <25 IU/mL (undetected) at Week 8
Time Frame up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (All patients who were randomized and received at least 1 dose of the trial medication)
Arm/Group Title Faldaprevir 120 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort I Relapser Patients - Cohort II Partial Responder Patients - Cohort II Null Responder Patients - Cohort II Breakthrough Patients - Cohort II
Hide Arm/Group Description:
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
Overall Number of Participants Analyzed 44 43 29 3 10 2
Measure Type: Number
Unit of Measure: percentage of participants
97.7 93.0 96.6 100.0 70.0 50.0
5.Secondary Outcome
Title Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES
Hide Description This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Time Frame EOT (up to Week 24 or 48)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (All patients who were randomized and received at least 1 dose of the trial medication)
Arm/Group Title Faldaprevir 120 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort I Relapser Patients - Cohort II Partial Responder Patients - Cohort II Null Responder Patients - Cohort II Breakthrough Patients - Cohort II
Hide Arm/Group Description:
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
Overall Number of Participants Analyzed 44 43 29 3 10 2
Measure Type: Number
Unit of Measure: participants
SVR12=Yes 38 32 25 2 4 1
SVR12=Yes, BL normal to EOT normal 16 18 17 2 1 1
SVR12=Yes, BL elevated to EOT normal 16 10 7 0 3 0
SVR12=Yes, no BL or EOT data available 0 0 0 0 0 0
6.Secondary Outcome
Title Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO
Hide Description This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Time Frame EOT (up to Week 24 or 48)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (All patients who were randomized and received at least 1 dose of the trial medication)
Arm/Group Title Faldaprevir 120 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort I Relapser Patients - Cohort II Partial Responder Patients - Cohort II Null Responder Patients - Cohort II Breakthrough Patients - Cohort II
Hide Arm/Group Description:
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
Overall Number of Participants Analyzed 44 43 29 3 10 2
Measure Type: Number
Unit of Measure: participants
SVR12=No 6 11 4 1 6 1
SVR12=No, BL normal to EOT normal 4 6 3 0 4 0
SVR12=No, BL elevated to EOT normal 2 2 0 1 2 1
SVR12=No, no BL or EOT data available 0 0 0 0 0 0
7.Secondary Outcome
Title Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
Hide Description This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Time Frame 12 weeks after the EOT (up to Week 36 or 60)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (All patients who were randomized and received at least 1 dose of the trial medication)
Arm/Group Title Faldaprevir 120 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort I Relapser Patients - Cohort II Partial Responder Patients - Cohort II Null Responder Patients - Cohort II Breakthrough Patients - Cohort II
Hide Arm/Group Description:
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
Overall Number of Participants Analyzed 44 43 29 3 10 2
Measure Type: Number
Unit of Measure: participants
SVR12=Yes 38 32 25 2 4 1
SVR12=Yes, BL normal to SVR12 normal 17 18 18 2 1 1
SVR12=Yes, BL elevated to SVR12 normal 19 12 7 0 3 0
SVR12=Yes, no BL or SVR12 data available 0 1 0 0 0 0
8.Secondary Outcome
Title Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
Hide Description This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Time Frame 12 weeks after the EOT (up to Week 36 or 60)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (All patients who were randomized and received at least 1 dose of the trial medication)
Arm/Group Title Faldaprevir 120 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort I Relapser Patients - Cohort II Partial Responder Patients - Cohort II Null Responder Patients - Cohort II Breakthrough Patients - Cohort II
Hide Arm/Group Description:
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
Overall Number of Participants Analyzed 44 43 29 3 10 2
Measure Type: Number
Unit of Measure: participants
SVR12=No 6 11 4 1 6 1
SVR12=No, BL normal to SVR12 normal 2 4 2 0 0 0
SVR12=No, BL elevated to SVR12 normal 0 2 0 1 1 0
SVR12=No, no BL or SVR12 data available 1 4 1 0 2 1
9.Secondary Outcome
Title Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES
Hide Description This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Time Frame EOT (up to Week 24 or 48)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (All patients who were randomized and received at least 1 dose of the trial medication)
Arm/Group Title Faldaprevir 120 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort I Relapser Patients - Cohort II Partial Responder Patients - Cohort II Null Responder Patients - Cohort II Breakthrough Patients - Cohort II
Hide Arm/Group Description:
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
Overall Number of Participants Analyzed 44 43 29 3 10 2
Measure Type: Number
Unit of Measure: participants
SVR12=Yes 38 32 25 2 4 1
SVR12=Yes, BL normal to EOT normal 21 18 16 2 1 1
SVR12=Yes, BL elevated to EOT normal 11 9 7 0 3 0
SVR12=Yes, no BL or EOT data available 0 0 0 0 0 0
10.Secondary Outcome
Title Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO
Hide Description This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Time Frame EOT (up to Week 24 or 48)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (All patients who were randomized and received at least 1 dose of the trial medication)
Arm/Group Title Faldaprevir 120 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort I Relapser Patients - Cohort II Partial Responder Patients - Cohort II Null Responder Patients - Cohort II Breakthrough Patients - Cohort II
Hide Arm/Group Description:
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
Overall Number of Participants Analyzed 44 43 29 3 10 2
Measure Type: Number
Unit of Measure: participants
SVR12=No 6 11 4 1 6 1
SVR12=No, BL normal to EOT normal 4 6 2 1 4 0
SVR12=No, BL elevated to EOT normal 2 3 0 0 2 1
SVR12=No, no BL or EOT data available 0 0 0 0 0 0
11.Secondary Outcome
Title Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
Hide Description This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Time Frame 12 weeks after the EOT (up to Week 36 or 60)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (All patients who were randomized and received at least 1 dose of the trial medication)
Arm/Group Title Faldaprevir 120 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort I Relapser Patients - Cohort II Partial Responder Patients - Cohort II Null Responder Patients - Cohort II Breakthrough Patients - Cohort II
Hide Arm/Group Description:
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
Overall Number of Participants Analyzed 44 43 29 3 10 2
Measure Type: Number
Unit of Measure: participants
SVR12=Yes 38 32 25 2 4 1
SVR12=Yes, BL normal to SVR12 normal 23 18 18 2 1 1
SVR12=Yes, BL elevated to SVR12 normal 13 12 7 0 3 0
SVR12=Yes, no BL or SVR12 data available 0 1 0 0 0 0
12.Secondary Outcome
Title Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
Hide Description This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Time Frame 12 weeks after the EOT (up to Week 36 or 60)
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Hide Analysis Population Description
FAS (All patients who were randomized and received at least 1 dose of the trial medication)
Arm/Group Title Faldaprevir 120 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort I Relapser Patients - Cohort II Partial Responder Patients - Cohort II Null Responder Patients - Cohort II Breakthrough Patients - Cohort II
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Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
Overall Number of Participants Analyzed 44 43 29 3 10 2
Measure Type: Number
Unit of Measure: participants
SVR12=No 6 11 4 1 6 1
SVR12=No, BL normal to SVR12 normal 2 3 1 1 1 0
SVR12=No, BL elevated to SVR12 normal 1 1 0 0 0 0
SVR12=No, no BL or SVR12 data available 1 4 1 0 2 1
Time Frame Up to 48 weeks + 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Faldaprevir 120 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort II
Hide Arm/Group Description Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 weeks in treatment-naive patients. Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFN/RBV for 24 weeks in treatment-naive patients. Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
All-Cause Mortality
Faldaprevir 120 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort II
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Faldaprevir 120 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort II
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/44 (6.82%)   4/43 (9.30%)   1/44 (2.27%) 
Blood and lymphatic system disorders       
Thrombocytopenia  1  0/44 (0.00%)  0/43 (0.00%)  1/44 (2.27%) 
Ear and labyrinth disorders       
Vertigo  1  0/44 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Gastrointestinal disorders       
Mallory-Weiss syndrome  1  1/44 (2.27%)  0/43 (0.00%)  0/44 (0.00%) 
Nausea  1  1/44 (2.27%)  1/43 (2.33%)  0/44 (0.00%) 
Vomiting  1  0/44 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
General disorders       
Malaise  1  0/44 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Infections and infestations       
Renal abscess  1  1/44 (2.27%)  0/43 (0.00%)  0/44 (0.00%) 
Skin and subcutaneous tissue disorders       
Erythema multiforme  1  0/44 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Rash  1  0/44 (0.00%)  1/43 (2.33%)  0/44 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 16.1
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 q.d - Cohort I Faldaprevir 240 mg q.d - Cohort I Faldaprevir 240 mg q.d - Cohort II
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   44/44 (100.00%)   43/43 (100.00%)   44/44 (100.00%) 
Blood and lymphatic system disorders       
Anaemia  1  12/44 (27.27%)  16/43 (37.21%)  13/44 (29.55%) 
Leukopenia  1  5/44 (11.36%)  2/43 (4.65%)  1/44 (2.27%) 
Neutropenia  1  9/44 (20.45%)  4/43 (9.30%)  5/44 (11.36%) 
Thrombocytopenia  1  5/44 (11.36%)  4/43 (9.30%)  4/44 (9.09%) 
Eye disorders       
Conjunctival haemorrhage  1  0/44 (0.00%)  3/43 (6.98%)  1/44 (2.27%) 
Dry eye  1  4/44 (9.09%)  5/43 (11.63%)  2/44 (4.55%) 
Retinal exudates  1  0/44 (0.00%)  4/43 (9.30%)  0/44 (0.00%) 
Retinal haemorrhage  1  0/44 (0.00%)  4/43 (9.30%)  2/44 (4.55%) 
Retinopathy  1  1/44 (2.27%)  4/43 (9.30%)  3/44 (6.82%) 
Gastrointestinal disorders       
Abdominal discomfort  1  1/44 (2.27%)  6/43 (13.95%)  4/44 (9.09%) 
Abdominal pain  1  0/44 (0.00%)  3/43 (6.98%)  1/44 (2.27%) 
Abdominal pain upper  1  1/44 (2.27%)  3/43 (6.98%)  1/44 (2.27%) 
Cheilitis  1  2/44 (4.55%)  4/43 (9.30%)  4/44 (9.09%) 
Constipation  1  5/44 (11.36%)  6/43 (13.95%)  2/44 (4.55%) 
Diarrhoea  1  7/44 (15.91%)  19/43 (44.19%)  23/44 (52.27%) 
Dyspepsia  1  5/44 (11.36%)  4/43 (9.30%)  2/44 (4.55%) 
Nausea  1  18/44 (40.91%)  24/43 (55.81%)  28/44 (63.64%) 
Stomatitis  1  6/44 (13.64%)  6/43 (13.95%)  3/44 (6.82%) 
Vomiting  1  10/44 (22.73%)  20/43 (46.51%)  21/44 (47.73%) 
General disorders       
Fatigue  1  5/44 (11.36%)  4/43 (9.30%)  8/44 (18.18%) 
Injection site erythema  1  1/44 (2.27%)  3/43 (6.98%)  2/44 (4.55%) 
Injection site reaction  1  13/44 (29.55%)  16/43 (37.21%)  10/44 (22.73%) 
Malaise  1  12/44 (27.27%)  8/43 (18.60%)  10/44 (22.73%) 
Pyrexia  1  35/44 (79.55%)  33/43 (76.74%)  35/44 (79.55%) 
Hepatobiliary disorders       
Hyperbilirubinaemia  1  6/44 (13.64%)  6/43 (13.95%)  5/44 (11.36%) 
Jaundice  1  5/44 (11.36%)  12/43 (27.91%)  10/44 (22.73%) 
Infections and infestations       
Cystitis  1  2/44 (4.55%)  1/43 (2.33%)  4/44 (9.09%) 
Nasopharyngitis  1  3/44 (6.82%)  4/43 (9.30%)  4/44 (9.09%) 
Investigations       
Haemoglobin decreased  1  5/44 (11.36%)  6/43 (13.95%)  8/44 (18.18%) 
Neutrophil count decreased  1  1/44 (2.27%)  4/43 (9.30%)  2/44 (4.55%) 
Platelet count decreased  1  2/44 (4.55%)  4/43 (9.30%)  3/44 (6.82%) 
Weight decreased  1  1/44 (2.27%)  0/43 (0.00%)  4/44 (9.09%) 
White blood cell count decreased  1  1/44 (2.27%)  5/43 (11.63%)  2/44 (4.55%) 
Metabolism and nutrition disorders       
Decreased appetite  1  9/44 (20.45%)  16/43 (37.21%)  15/44 (34.09%) 
Dehydration  1  0/44 (0.00%)  2/43 (4.65%)  3/44 (6.82%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  7/44 (15.91%)  8/43 (18.60%)  7/44 (15.91%) 
Back pain  1  4/44 (9.09%)  1/43 (2.33%)  4/44 (9.09%) 
Myalgia  1  6/44 (13.64%)  4/43 (9.30%)  3/44 (6.82%) 
Nervous system disorders       
Dysgeusia  1  3/44 (6.82%)  6/43 (13.95%)  8/44 (18.18%) 
Headache  1  15/44 (34.09%)  13/43 (30.23%)  14/44 (31.82%) 
Hypoaesthesia  1  3/44 (6.82%)  1/43 (2.33%)  1/44 (2.27%) 
Psychiatric disorders       
Insomnia  1  10/44 (22.73%)  4/43 (9.30%)  1/44 (2.27%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  2/44 (4.55%)  3/43 (6.98%)  2/44 (4.55%) 
Upper respiratory tract inflammation  1  3/44 (6.82%)  0/43 (0.00%)  0/44 (0.00%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  15/44 (34.09%)  14/43 (32.56%)  17/44 (38.64%) 
Dermatitis contact  1  1/44 (2.27%)  2/43 (4.65%)  4/44 (9.09%) 
Dry skin  1  3/44 (6.82%)  7/43 (16.28%)  1/44 (2.27%) 
Eczema  1  1/44 (2.27%)  4/43 (9.30%)  1/44 (2.27%) 
Erythema  1  2/44 (4.55%)  0/43 (0.00%)  3/44 (6.82%) 
Photosensitivity reaction  1  0/44 (0.00%)  3/43 (6.98%)  0/44 (0.00%) 
Pruritus  1  13/44 (29.55%)  8/43 (18.60%)  12/44 (27.27%) 
Rash  1  18/44 (40.91%)  26/43 (60.47%)  23/44 (52.27%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 16.1
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
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Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01579474     History of Changes
Other Study ID Numbers: 1220.54
First Submitted: April 12, 2012
First Posted: April 18, 2012
Results First Submitted: July 3, 2015
Results First Posted: August 3, 2015
Last Update Posted: August 3, 2015