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Trial record 11 of 28 for:    RNA | BI 201335 OR faldaprevir

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

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ClinicalTrials.gov Identifier: NCT01343888
Recruitment Status : Completed
First Posted : April 28, 2011
Results First Posted : September 18, 2015
Last Update Posted : September 18, 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: PegIFN/RBV
Drug: BI 201335
Drug: Placebo
Enrollment 656
Recruitment Details  
Pre-assignment Details All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that they (the subject) met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.
Arm/Group Title Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
Hide Arm/Group Description Faldaprevir (BI 201335) 120 mg once daily (oral) plus Pegylated Interferon-alpha (PegIFN)/ Ribavirin (RBV) (subcutaneous injection/oral) for 12 or 24 weeks, depending on achievement of early treatment success (ETS). Patients with ETS received this treatment for 12 weeks and subsequently PegIFN/RBV alone up to Week 24; patients without ETS received this treatment for 24 weeks and subsequently PegIFN/RBV alone up to Week 48. Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24. Patients with ETS stopped all study medication at Week 24; patients without ETS subsequently received PegIFN/RBV alone up to Week 48. Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
Period Title: Overall Study
Started 259 [1] 261 [2] 132 [3]
Completed 234 222 110
Not Completed 25 39 22
Reason Not Completed
Adverse Event             12             22             5
Lack of Efficacy             9             9             13
Lost to Follow-up             0             2             1
Protocol Violation             0             2             0
Withdrawal by Subject             4             4             2
other than stated above             0             0             1
[1]
261 subject randomized; 259 subjects treated with at least one dose; 2 subjects were not treated
[2]
262 subject randomized; 261 subjects treated with at least one dose; 1 subject was not treated
[3]
133 subject randomized; 132 subjects treated with at least one dose; 1 subject was not treated
Arm/Group Title Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV Total
Hide Arm/Group Description Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48. Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48. Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48. Total of all reporting groups
Overall Number of Baseline Participants 259 261 132 652
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 259 participants 261 participants 132 participants 652 participants
47.9  (11.44) 48.3  (11.89) 46.6  (12.53) 47.8  (11.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 259 participants 261 participants 132 participants 652 participants
Female
138
  53.3%
115
  44.1%
57
  43.2%
310
  47.5%
Male
121
  46.7%
146
  55.9%
75
  56.8%
342
  52.5%
1.Primary Outcome
Title Sustained Virological Response 12 Weeks Post-treatment (SVR12)
Hide Description Sustained Virological Response 12 weeks post-treatment (SVR12), defined as plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level < 25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
Time Frame 12 weeks post treatment, up to 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
Arm/Group Title Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
Hide Arm/Group Description:
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
Overall Number of Participants Analyzed 259 261 132
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
79.5
(74.6 to 84.4)
80.5
(75.6 to 85.3)
52.3
(43.8 to 60.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Faldaprevir 120mg and PegIFN/RBV, Placebo and PegIFN/RBV
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 race
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Koch's method
Estimated Value 27.5
Confidence Interval (2-Sided) 95%
17.9 to 37.0
Estimation Comments adjusted for genotype and race using Koch's method, with continuity correction
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Faldaprevir 240mg and PegIFN/RBV, Placebo and PegIFN/RBV
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 race
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Koch's methond
Estimated Value 28.6
Confidence Interval (2-Sided) 95%
19.0 to 38.2
Estimation Comments adjusted for genotype and race using Koch's method, with continuity correction
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Faldaprevir 120mg and PegIFN/RBV, Faldaprevir 240mg and PegIFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Koch's method
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-7.9 to 5.8
Estimation Comments adjusted for genotype and race using Koch's method, with continuity correction
2.Secondary Outcome
Title Sustained Virological Response 24 Weeks Post-treatment (SVR24)
Hide Description Sustained Virological Response 24 weeks post-treatment (SVR24), defined as plasma 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
Arm/Group Title Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
Hide Arm/Group Description:
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
Overall Number of Participants Analyzed 259 261 132
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
79.2
(74.2 to 84.1)
79.7
(74.8 to 84.6)
52.3
(43.8 to 60.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Faldaprevir 120mg and PegIFN/RBV, Placebo and PegIFN/RBV
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 race
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Koch's method
Estimated Value 27.1
Confidence Interval (2-Sided) 95%
17.5 to 36.7
Estimation Comments adjusted for genotype and race using Koch's method, with continuity correction
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Faldaprevir 240mg and PegIFN/RBV, Placebo and PegIFN/RBV
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 race
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Koch's method
Estimated Value 27.8
Confidence Interval (2-Sided) 95%
18.2 to 37.4
Estimation Comments adjusted for genotype and race using Koch's method, with continuity correction
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Faldaprevir 120mg and PegIFN/RBV, Faldaprevir 240mg and PegIFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Koch's method
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-7.6 to 6.3
Estimation Comments adjusted for genotype and race using Koch's method, with continuity correction
3.Secondary Outcome
Title Early Treatment Success (ETS)
Time Frame week 4 and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
Arm/Group Title Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
Hide Arm/Group Description:
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
Overall Number of Participants Analyzed 259 261 132
Measure Type: Number
Unit of Measure: percentage of participants
87.3 89.3 22.0
4.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 12 weeks post treatment, up to 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
Arm/Group Title Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
Hide Arm/Group Description:
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
Overall Number of Participants Analyzed 259 261 132
Measure Type: Number
Unit of Measure: participants
SVR12 = Yes 206 210 69
SVR12 = Yes, BL normal to EoT normal 66 68 27
SVR12 = Yes, BL elevated to EoT normal 97 115 31
SVR12 = Yes, No ALT data available at EoT 0 0 0
5.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 12 weeks post treatment, up to 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
Arm/Group Title Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
Hide Arm/Group Description:
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
Overall Number of Participants Analyzed 259 261 132
Measure Type: Number
Unit of Measure: participants
SVR12 = No 53 51 63
SVR12 = No, BL normal to EoT normal 15 10 15
SVR12 = No, BL elevated to EoT normal 16 22 20
SVR12 = No, No ALT data available at EoT 0 0 1
6.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. BL = Baseline
Time Frame 12 weeks post treatment, up to 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
Arm/Group Title Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
Hide Arm/Group Description:
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
Overall Number of Participants Analyzed 259 261 132
Measure Type: Number
Unit of Measure: participants
SVR12 = Yes 206 210 69
SVR12 = Yes, BL normal to SVR12 normal 72 73 27
SVR12 = Yes, BL elevated to SVR12 normal 125 126 39
SVR12 = Yes, No ALT data available post-treatment 4 5 1
7.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. BL = Baseline
Time Frame 12 weeks post treatment, up to 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
Arm/Group Title Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
Hide Arm/Group Description:
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
Overall Number of Participants Analyzed 259 261 132
Measure Type: Number
Unit of Measure: participants
SVR12 = No 53 51 63
SVR12 = No, BL normal to SVR12 normal 9 5 5
SVR12 = No, BL elevated to SVR12 normal 6 6 1
SVR12 = No, No ALT data available post-treatment 8 14 45
8.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 12 weeks post treatment, up to 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
Arm/Group Title Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
Hide Arm/Group Description:
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
Overall Number of Participants Analyzed 259 261 132
Measure Type: Number
Unit of Measure: participants
SVR12 = Yes 206 210 69
SVR12 = Yes, BL normal to EoT normal 95 99 34
SVR12 = Yes, BL elevated to EoT normal 74 76 25
SVR12 = Yes, No AST data available at EoT 0 0 0
9.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 12 weeks post treatment, up to 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
Arm/Group Title Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
Hide Arm/Group Description:
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
Overall Number of Participants Analyzed 259 261 132
Measure Type: Number
Unit of Measure: participants
SVR12 = No 53 51 63
SVR12 = No, BL normal to EoT normal 17 16 21
SVR12 = No, BL elevated to EoT normal 14 16 13
SVR12 = No, No AST data available at EoT 0 0 1
10.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. BL = Baseline
Time Frame 12 weeks post treatment, up to 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
Arm/Group Title Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
Hide Arm/Group Description:
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
Overall Number of Participants Analyzed 259 261 132
Measure Type: Number
Unit of Measure: participants
SVR12 = Yes 206 210 69
SVR12 = Yes, BL normal to SVR12 normal 102 109 39
SVR12 = Yes, BL elevated to SVR12 normal 90 88 27
SVR12 = Yes, No AST data available post-treatment 5 5 1
11.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. BL = Baseline
Time Frame 12 weeks post treatment, up to 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
Arm/Group Title Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
Hide Arm/Group Description:
Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
Overall Number of Participants Analyzed 259 261 132
Measure Type: Number
Unit of Measure: participants
SVR12 = No 53 51 63
SVR12 = No, BL normal to SVR12 normal 10 10 5
SVR12 = No, BL elevated to SVR12 normal 10 5 1
SVR12 = No, No AST data available post-treatment 8 14 45
Time Frame The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
Adverse Event Reporting Description AEs that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization [safety set (SAF)] were included in the presentation of AE data.
 
Arm/Group Title Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
Hide Arm/Group Description Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48. Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48. Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
All-Cause Mortality
Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/259 (6.56%)   17/261 (6.51%)   8/132 (6.06%) 
Blood and lymphatic system disorders       
Anaemia  1  1/259 (0.39%)  2/261 (0.77%)  1/132 (0.76%) 
Histiocytosis haematophagic  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (0.00%) 
Idiopathic thrombocytopenic purpura  1  0/259 (0.00%)  1/261 (0.38%)  0/132 (0.00%) 
Leukopenia  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (0.00%) 
Pancytopenia  1  0/259 (0.00%)  1/261 (0.38%)  0/132 (0.00%) 
Thrombocytopenia  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (0.00%) 
Cardiac disorders       
Atrial fibrillation  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (0.00%) 
Myocardial infarction  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (0.00%) 
Endocrine disorders       
Hypoparathyroidism  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (0.00%) 
Eye disorders       
Optic ischaemic neuropathy  1  0/259 (0.00%)  1/261 (0.38%)  0/132 (0.00%) 
Retinopathy  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (0.00%) 
Gastrointestinal disorders       
Haemorrhoids  1  0/259 (0.00%)  1/261 (0.38%)  0/132 (0.00%) 
Inguinal hernia  1  0/259 (0.00%)  0/261 (0.00%)  1/132 (0.76%) 
Pancreatitis  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (0.00%) 
Vomiting  1  0/259 (0.00%)  2/261 (0.77%)  0/132 (0.00%) 
General disorders       
Asthenia  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (0.00%) 
Chest pain  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (0.00%) 
Pyrexia  1  0/259 (0.00%)  1/261 (0.38%)  0/132 (0.00%) 
Hepatobiliary disorders       
Cholecystitis  1  0/259 (0.00%)  0/261 (0.00%)  1/132 (0.76%) 
Hepatic lesion  1  0/259 (0.00%)  0/261 (0.00%)  1/132 (0.76%) 
Immune system disorders       
Hypersensitivity  1  0/259 (0.00%)  1/261 (0.38%)  0/132 (0.00%) 
Sarcoidosis  1  0/259 (0.00%)  1/261 (0.38%)  0/132 (0.00%) 
Infections and infestations       
Bronchopneumonia  1  0/259 (0.00%)  1/261 (0.38%)  0/132 (0.00%) 
Diverticulitis  1  0/259 (0.00%)  0/261 (0.00%)  1/132 (0.76%) 
Pneumonia  1  0/259 (0.00%)  1/261 (0.38%)  0/132 (0.00%) 
Urinary tract infection  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (0.00%) 
Injury, poisoning and procedural complications       
Gun shot wound  1  0/259 (0.00%)  0/261 (0.00%)  1/132 (0.76%) 
Subdural haematoma  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (0.00%) 
Metabolism and nutrition disorders       
Diabetes mellitus  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (0.00%) 
Musculoskeletal and connective tissue disorders       
Muscular weakness  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (0.00%) 
Polymyositis  1  0/259 (0.00%)  0/261 (0.00%)  1/132 (0.76%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cervix carcinoma  1  0/259 (0.00%)  1/261 (0.38%)  0/132 (0.00%) 
Nervous system disorders       
Cerebrovascular accident  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (0.00%) 
Cubital tunnel syndrome  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (0.00%) 
Dizziness  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (0.00%) 
Headache  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (0.00%) 
Sciatica  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (0.00%) 
Psychiatric disorders       
Psychotic disorder  1  0/259 (0.00%)  1/261 (0.38%)  0/132 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea exertional  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (0.00%) 
Epistaxis  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (0.00%) 
Skin and subcutaneous tissue disorders       
Blister  1  0/259 (0.00%)  0/261 (0.00%)  1/132 (0.76%) 
Drug eruption  1  0/259 (0.00%)  1/261 (0.38%)  0/132 (0.00%) 
Psoriasis  1  0/259 (0.00%)  1/261 (0.38%)  0/132 (0.00%) 
Rash  1  1/259 (0.39%)  1/261 (0.38%)  0/132 (0.00%) 
Rash maculo-papular  1  0/259 (0.00%)  0/261 (0.00%)  1/132 (0.76%) 
Vascular disorders       
Hypotension  1  1/259 (0.39%)  0/261 (0.00%)  0/132 (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 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   246/259 (94.98%)   250/261 (95.79%)   120/132 (90.91%) 
Blood and lymphatic system disorders       
Anaemia  1  46/259 (17.76%)  43/261 (16.48%)  23/132 (17.42%) 
Neutropenia  1  32/259 (12.36%)  25/261 (9.58%)  18/132 (13.64%) 
Gastrointestinal disorders       
Abdominal pain  1  11/259 (4.25%)  15/261 (5.75%)  10/132 (7.58%) 
Abdominal pain upper  1  18/259 (6.95%)  24/261 (9.20%)  14/132 (10.61%) 
Constipation  1  11/259 (4.25%)  16/261 (6.13%)  5/132 (3.79%) 
Diarrhoea  1  53/259 (20.46%)  68/261 (26.05%)  17/132 (12.88%) 
Dry mouth  1  8/259 (3.09%)  6/261 (2.30%)  9/132 (6.82%) 
Dyspepsia  1  12/259 (4.63%)  14/261 (5.36%)  9/132 (6.82%) 
Nausea  1  73/259 (28.19%)  95/261 (36.40%)  19/132 (14.39%) 
Stomatitis  1  12/259 (4.63%)  11/261 (4.21%)  7/132 (5.30%) 
Vomiting  1  28/259 (10.81%)  52/261 (19.92%)  6/132 (4.55%) 
General disorders       
Asthenia  1  53/259 (20.46%)  43/261 (16.48%)  27/132 (20.45%) 
Fatigue  1  66/259 (25.48%)  77/261 (29.50%)  35/132 (26.52%) 
Influenza like illness  1  40/259 (15.44%)  52/261 (19.92%)  21/132 (15.91%) 
Irritability  1  19/259 (7.34%)  18/261 (6.90%)  9/132 (6.82%) 
Malaise  1  20/259 (7.72%)  16/261 (6.13%)  12/132 (9.09%) 
Pyrexia  1  57/259 (22.01%)  53/261 (20.31%)  32/132 (24.24%) 
Hepatobiliary disorders       
Hyperbilirubinaemia  1  4/259 (1.54%)  14/261 (5.36%)  1/132 (0.76%) 
Jaundice  1  17/259 (6.56%)  48/261 (18.39%)  1/132 (0.76%) 
Infections and infestations       
Nasopharyngitis  1  14/259 (5.41%)  16/261 (6.13%)  10/132 (7.58%) 
Investigations       
Haemoglobin decreased  1  15/259 (5.79%)  5/261 (1.92%)  7/132 (5.30%) 
Weight decreased  1  13/259 (5.02%)  15/261 (5.75%)  10/132 (7.58%) 
Metabolism and nutrition disorders       
Decreased appetite  1  35/259 (13.51%)  52/261 (19.92%)  22/132 (16.67%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  19/259 (7.34%)  20/261 (7.66%)  14/132 (10.61%) 
Back pain  1  14/259 (5.41%)  8/261 (3.07%)  10/132 (7.58%) 
Myalgia  1  22/259 (8.49%)  19/261 (7.28%)  20/132 (15.15%) 
Nervous system disorders       
Disturbance in attention  1  10/259 (3.86%)  8/261 (3.07%)  7/132 (5.30%) 
Dizziness  1  17/259 (6.56%)  21/261 (8.05%)  13/132 (9.85%) 
Headache  1  76/259 (29.34%)  70/261 (26.82%)  40/132 (30.30%) 
Dysgeusia  1  13/259 (5.02%)  10/261 (3.83%)  5/132 (3.79%) 
Psychiatric disorders       
Depression  1  20/259 (7.72%)  12/261 (4.60%)  8/132 (6.06%) 
Insomnia  1  38/259 (14.67%)  32/261 (12.26%)  22/132 (16.67%) 
Sleep disorder  1  12/259 (4.63%)  14/261 (5.36%)  5/132 (3.79%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  30/259 (11.58%)  28/261 (10.73%)  20/132 (15.15%) 
Dyspnoea  1  17/259 (6.56%)  19/261 (7.28%)  16/132 (12.12%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  42/259 (16.22%)  47/261 (18.01%)  15/132 (11.36%) 
Dry skin  1  35/259 (13.51%)  45/261 (17.24%)  17/132 (12.88%) 
Erythema  1  9/259 (3.47%)  18/261 (6.90%)  6/132 (4.55%) 
Pruritus  1  82/259 (31.66%)  78/261 (29.89%)  41/132 (31.06%) 
Rash  1  69/259 (26.64%)  70/261 (26.82%)  25/132 (18.94%) 
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.
Other - 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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01343888     History of Changes
Other Study ID Numbers: 1220.30
2010-021716-42 ( EudraCT Number: EudraCT )
First Submitted: April 20, 2011
First Posted: April 28, 2011
Results First Submitted: July 3, 2015
Results First Posted: September 18, 2015
Last Update Posted: September 18, 2015