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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 2)

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ClinicalTrials.gov Identifier: NCT01297270
Recruitment Status : Completed
First Posted : February 16, 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: BI201335
Drug: PegIFN/RBV
Drug: Placebo
Enrollment 658
Recruitment Details  
Pre-assignment Details  
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), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone. Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone. Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
Period Title: Overall Study
Started 262 264 132
Completed 217 192 103
Not Completed 45 72 29
Reason Not Completed
Adverse Event             19             32             5
Lack of Efficacy             15             17             15
Lost to Follow-up             1             2             1
Protocol Violation             0             2             0
Withdrawal by Subject             7             15             7
Other reason not defined above             3             3             1
Not treated             0             1             0
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), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone. Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone. Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone. Total of all reporting groups
Overall Number of Baseline Participants 262 263 132 657
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 262 participants 263 participants 132 participants 657 participants
50.2  (10.05) 50.4  (9.40) 50.2  (8.78) 50.3  (9.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 262 participants 263 participants 132 participants 657 participants
Female
105
  40.1%
109
  41.4%
54
  40.9%
268
  40.8%
Male
157
  59.9%
154
  58.6%
78
  59.1%
389
  59.2%
1.Primary Outcome
Title Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
Hide Description Percentage of participants with sustained virologic response 12 weeks post treatment (SVR12) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
Time Frame 12 weeks post treatment, up to 60 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
Overall Number of Participants Analyzed 262 263 132
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67.9
(62.3 to 73.6)
64.3
(58.5 to 70.1)
47.0
(38.5 to 55.5)
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 [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 20.7
Confidence Interval (2-Sided) 95%
10.7 to 30.6
Estimation Comments Estimate 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 0.0007
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 17.4
Confidence Interval (2-Sided) 95%
7.3 to 27.4
Estimation Comments Estimate adjusted for genotype and race using Koch's method, with continuity correction
2.Secondary Outcome
Title Sustained Virologic Response 24 Weeks Post-treatment (SVR24)
Hide Description

Percentage of participants with sustained virologic response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.

Hepatitis C virus Ribonucleic acid (HCV RNA)

Time Frame 24 weeks post treatment, up to 72 weeks
Show Outcome Measure DataHide 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 and had SVR data at week 24.
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), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
Overall Number of Participants Analyzed 262 263 132
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67.2
(61.5 to 72.9)
62.7
(56.9 to 68.6)
46.2
(37.7 to 54.7)
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 [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 20.7
Confidence Interval (2-Sided) 95%
10.7 to 30.6
Estimation Comments Estimate 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 0.0014
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 16.6
Confidence Interval (2-Sided) 95%
6.5 to 26.7
Estimation Comments Estimate adjusted for genotype and race using Koch's method, with continuity correction
3.Secondary Outcome
Title Early Treatment Success (ETS)
Hide Description Percentage of participants with early treatment success (ETS), defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.
Time Frame Week 4 and week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
Overall Number of Participants Analyzed 262 263 132
Measure Type: Number
Unit of Measure: percentage of participants
80.2 79.1 15.9
4.Secondary Outcome
Title ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES
Hide Description The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients have sustained virological response 12 weeks post-treatment. BL = Baseline
Time Frame 12 weeks post treatment, up to 60 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
Overall Number of Participants Analyzed 262 263 132
Measure Type: Number
Unit of Measure: participants
SVR12 = Yes 178 169 62
SVR12 = Yes, BL normal to EOT normal 50 52 22
SVR12 = Yes, BL elevated to EOT normal 89 81 35
SVR12 = Yes, No ALT data available at EoT 0 0 0
5.Secondary Outcome
Title ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO
Hide Description The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline
Time Frame 12 weeks post treatment, up to 60 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
Overall Number of Participants Analyzed 262 263 132
Measure Type: Number
Unit of Measure: participants
SVR12 = No 84 94 70
SVR12 = No, BL normal to EOT normal 21 20 15
SVR12 = No, BL elevated to EOT normal 33 44 30
SVR12 = No, No ALT data available at EoT 3 5 1
6.Secondary Outcome
Title ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES
Hide Description The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline
Time Frame 12 weeks post treatment, up to 60 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
Overall Number of Participants Analyzed 262 263 132
Measure Type: Number
Unit of Measure: participants
SVR12 = Yes 178 169 62
SVR12 = Yes, BL normal to SVR12 normal 52 58 23
SVR12 = Yes, BL elevated to SVR12 normal 105 100 37
SVR12 = Yes, No ALT data available at SVR12 visit 9 3 0
7.Secondary Outcome
Title ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO
Hide Description The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline
Time Frame 12 weeks post treatment, up to 60 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
Overall Number of Participants Analyzed 262 263 132
Measure Type: Number
Unit of Measure: participants
SVR12 = No 84 94 70
SVR12 = No, BL normal to SVR12 normal 12 11 3
SVR12 = No, BL elevated to SVR12 normal 13 16 2
SVR12 = No, No ALT data available at SVR12 visit 23 34 54
8.Secondary Outcome
Title AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES
Hide Description The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline
Time Frame 12 weeks post treatment, up to 60 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
Overall Number of Participants Analyzed 262 263 132
Measure Type: Number
Unit of Measure: participants
SVR12 = Yes 178 169 62
SVR12 = Yes, BL normal to EOT normal 70 78 26
SVR12 = Yes, BL elevated to EOT normal 65 51 26
SVR12 = Yes, No AST data available at EoT 0 0 0
9.Secondary Outcome
Title AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO
Hide Description The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline
Time Frame 12 weeks post treatment, up to 60 weeks
Show Outcome Measure DataHide 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), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
Overall Number of Participants Analyzed 262 263 132
Measure Type: Number
Unit of Measure: participants
SVR12 = No 84 94 70
SVR12 = No, BL normal to EOT normal 27 24 17
SVR12 = No, BL elevated to EOT normal 27 33 26
SVR12 = No, No AST data available at EoT 3 5 1
10.Secondary Outcome
Title AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES
Hide Description The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline
Time Frame 12 weeks post treatment, up to 60 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
Overall Number of Participants Analyzed 262 263 132
Measure Type: Number
Unit of Measure: participants
SVR12 = Yes 178 169 62
SVR12 = Yes, BL normal to SVR12 normal 71 84 29
SVR12 = Yes, BL elevated to SVR12 normal 86 71 30
SVR12 = Yes, No AST data available at SVR12 visit 9 3 0
11.Secondary Outcome
Title AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO
Hide Description The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline
Time Frame 12 weeks post treatment, up to 60 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
Overall Number of Participants Analyzed 262 263 132
Measure Type: Number
Unit of Measure: participants
SVR12 = No 84 94 70
SVR12 = No, BL normal to SVR12 normal 13 11 3
SVR12 = No, BL elevated to SVR12 normal 15 12 1
SVR12 = No, No AST data available at SVR12 visit 23 34 54
Time Frame Up to 4 weeks after treatment discontinuation (Up to 48 weeks treatment)
Adverse Event Reporting Description Adverse events (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), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone. Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone. Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
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   21/262 (8.02%)   26/263 (9.89%)   8/132 (6.06%) 
Blood and lymphatic system disorders       
Anaemia  1  2/262 (0.76%)  0/263 (0.00%)  1/132 (0.76%) 
Neutropenia  1  1/262 (0.38%)  1/263 (0.38%)  0/132 (0.00%) 
Pancytopenia  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Thrombocytopenia  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Cardiac disorders       
Acute myocardial infarction  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Angina pectoris  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Congenital, familial and genetic disorders       
Epidermolysis  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Eye disorders       
Optic ischaemic neuropathy  1  0/262 (0.00%)  0/263 (0.00%)  1/132 (0.76%) 
Gastrointestinal disorders       
Ascites  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Diarrhoea  1  0/262 (0.00%)  2/263 (0.76%)  0/132 (0.00%) 
Duodenal ulcer haemorrhage  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Large intestine perforation  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Nausea  1  0/262 (0.00%)  2/263 (0.76%)  0/132 (0.00%) 
Oesophageal varices haemorrhage  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Pancreatitis  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Umbilical hernia  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Vomiting  1  0/262 (0.00%)  3/263 (1.14%)  0/132 (0.00%) 
General disorders       
Malaise  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Hepatobiliary disorders       
Bile duct stone  1  0/262 (0.00%)  0/263 (0.00%)  1/132 (0.76%) 
Cholecystitis  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Hepatic cirrhosis  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Hepatic failure  1  0/262 (0.00%)  2/263 (0.76%)  0/132 (0.00%) 
Immune system disorders       
Hypersensitivity  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Infections and infestations       
Cellulitis  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Diverticulitis  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Infective chondritis  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Pneumonia  1  1/262 (0.38%)  1/263 (0.38%)  0/132 (0.00%) 
Sepsis  1  1/262 (0.38%)  1/263 (0.38%)  0/132 (0.00%) 
Subcutaneous abscess  1  1/262 (0.38%)  0/263 (0.00%)  1/132 (0.76%) 
Vulval abscess  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Injury, poisoning and procedural complications       
Accidental overdose  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Contusion  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Fibula fracture  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Jaw fracture  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Laceration  1  0/262 (0.00%)  0/263 (0.00%)  1/132 (0.76%) 
Ligament sprain  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Tibia fracture  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Hypocalcaemia  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Hypokalaemia  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Hyponatraemia  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Intervertebral disc protrusion  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Muscle spasms  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast cancer stage II  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Hepatocellular carcinoma  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Papillary thyroid cancer  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Superficial spreading melanoma stage unspecified  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Nervous system disorders       
Cerebral ischaemia  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous  1  0/262 (0.00%)  2/263 (0.76%)  0/132 (0.00%) 
Psychiatric disorders       
Bipolar disorder  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Depression  1  0/262 (0.00%)  1/263 (0.38%)  2/132 (1.52%) 
Drug dependence  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Mental status changes  1  0/262 (0.00%)  0/263 (0.00%)  1/132 (0.76%) 
Personality disorder  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Suicidal ideation  1  0/262 (0.00%)  1/263 (0.38%)  1/132 (0.76%) 
Suicide attempt  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Renal and urinary disorders       
Renal failure acute  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  0/262 (0.00%)  1/263 (0.38%)  0/132 (0.00%) 
Pulmonary embolism  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash  1  0/262 (0.00%)  2/263 (0.76%)  0/132 (0.00%) 
Rash maculo-papular  1  1/262 (0.38%)  0/263 (0.00%)  0/132 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 17.0
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   255/262 (97.33%)   258/263 (98.10%)   130/132 (98.48%) 
Blood and lymphatic system disorders       
Anaemia  1  59/262 (22.52%)  55/263 (20.91%)  27/132 (20.45%) 
Neutropenia  1  35/262 (13.36%)  24/263 (9.13%)  14/132 (10.61%) 
Thrombocytopenia  1  13/262 (4.96%)  14/263 (5.32%)  11/132 (8.33%) 
Eye disorders       
Ocular icterus  1  3/262 (1.15%)  14/263 (5.32%)  1/132 (0.76%) 
Gastrointestinal disorders       
Abdominal pain  1  20/262 (7.63%)  23/263 (8.75%)  10/132 (7.58%) 
Abdominal pain upper  1  15/262 (5.73%)  8/263 (3.04%)  9/132 (6.82%) 
Constipation  1  22/262 (8.40%)  14/263 (5.32%)  7/132 (5.30%) 
Diarrhoea  1  71/262 (27.10%)  89/263 (33.84%)  23/132 (17.42%) 
Dry mouth  1  15/262 (5.73%)  16/263 (6.08%)  6/132 (4.55%) 
Dyspepsia  1  26/262 (9.92%)  17/263 (6.46%)  3/132 (2.27%) 
Nausea  1  99/262 (37.79%)  150/263 (57.03%)  52/132 (39.39%) 
Vomiting  1  40/262 (15.27%)  70/263 (26.62%)  11/132 (8.33%) 
General disorders       
Asthenia  1  10/262 (3.82%)  19/263 (7.22%)  6/132 (4.55%) 
Chills  1  40/262 (15.27%)  38/263 (14.45%)  25/132 (18.94%) 
Fatigue  1  113/262 (43.13%)  133/263 (50.57%)  70/132 (53.03%) 
Influenza like illness  1  25/262 (9.54%)  14/263 (5.32%)  15/132 (11.36%) 
Injection site erythema  1  13/262 (4.96%)  13/263 (4.94%)  11/132 (8.33%) 
Injection site reaction  1  26/262 (9.92%)  13/263 (4.94%)  4/132 (3.03%) 
Pain  1  15/262 (5.73%)  22/263 (8.37%)  9/132 (6.82%) 
Pyrexia  1  38/262 (14.50%)  41/263 (15.59%)  20/132 (15.15%) 
Hepatobiliary disorders       
Hyperbilirubinaemia  1  8/262 (3.05%)  25/263 (9.51%)  0/132 (0.00%) 
Jaundice  1  6/262 (2.29%)  24/263 (9.13%)  0/132 (0.00%) 
Infections and infestations       
Bronchitis  1  5/262 (1.91%)  14/263 (5.32%)  2/132 (1.52%) 
Upper respiratory tract infection  1  18/262 (6.87%)  19/263 (7.22%)  9/132 (6.82%) 
Investigations       
Weight decreased  1  15/262 (5.73%)  20/263 (7.60%)  10/132 (7.58%) 
Metabolism and nutrition disorders       
Decreased appetite  1  54/262 (20.61%)  63/263 (23.95%)  26/132 (19.70%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  36/262 (13.74%)  36/263 (13.69%)  22/132 (16.67%) 
Back pain  1  15/262 (5.73%)  16/263 (6.08%)  11/132 (8.33%) 
Muscle spasms  1  2/262 (0.76%)  8/263 (3.04%)  7/132 (5.30%) 
Myalgia  1  47/262 (17.94%)  53/263 (20.15%)  37/132 (28.03%) 
Pain in extremity  1  11/262 (4.20%)  12/263 (4.56%)  8/132 (6.06%) 
Nervous system disorders       
Disturbance in attention  1  9/262 (3.44%)  14/263 (5.32%)  8/132 (6.06%) 
Dizziness  1  41/262 (15.65%)  39/263 (14.83%)  25/132 (18.94%) 
Dysgeusia  1  16/262 (6.11%)  15/263 (5.70%)  3/132 (2.27%) 
Headache  1  84/262 (32.06%)  81/263 (30.80%)  45/132 (34.09%) 
Hypoaesthesia  1  8/262 (3.05%)  5/263 (1.90%)  7/132 (5.30%) 
Psychiatric disorders       
Anxiety  1  15/262 (5.73%)  25/263 (9.51%)  14/132 (10.61%) 
Depression  1  32/262 (12.21%)  36/263 (13.69%)  11/132 (8.33%) 
Insomnia  1  71/262 (27.10%)  66/263 (25.10%)  38/132 (28.79%) 
Irritability  1  35/262 (13.36%)  32/263 (12.17%)  27/132 (20.45%) 
Renal and urinary disorders       
Chromaturia  1  5/262 (1.91%)  20/263 (7.60%)  0/132 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  46/262 (17.56%)  43/263 (16.35%)  21/132 (15.91%) 
Dyspnoea  1  31/262 (11.83%)  22/263 (8.37%)  20/132 (15.15%) 
Dyspnoea exertional  1  12/262 (4.58%)  17/263 (6.46%)  9/132 (6.82%) 
Nasal congestion  1  6/262 (2.29%)  7/263 (2.66%)  7/132 (5.30%) 
Oropharyngeal pain  1  15/262 (5.73%)  13/263 (4.94%)  8/132 (6.06%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  45/262 (17.18%)  51/263 (19.39%)  22/132 (16.67%) 
Dry skin  1  30/262 (11.45%)  37/263 (14.07%)  15/132 (11.36%) 
Hyperhidrosis  1  4/262 (1.53%)  4/263 (1.52%)  8/132 (6.06%) 
Pruritus  1  70/262 (26.72%)  94/263 (35.74%)  37/132 (28.03%) 
Rash  1  93/262 (35.50%)  105/263 (39.92%)  41/132 (31.06%) 
Rash macular  1  5/262 (1.91%)  14/263 (5.32%)  2/132 (1.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01297270     History of Changes
Other Study ID Numbers: 1220.47
2010-021716-42 ( EudraCT Number: EudraCT )
First Submitted: February 15, 2011
First Posted: February 16, 2011
Results First Submitted: July 3, 2015
Results First Posted: September 18, 2015
Last Update Posted: September 18, 2015