The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
678
BI 201335 once a day (QD) for 24 weeks
Pegylated Interferon-alpha for 48 weeks
Ribavirin (RBV) for 24 or 48 weeks
Sustained Virological Response 12 Weeks Post Treatment (SVR12)
Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
Time frame: 12 weeks post treatment, up to 60 weeks
Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)
Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.
Time frame: 24 weeks post treatment, up to 72 weeks
Early Treatment Success (ETS)
Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level \<25 IU/mL (undetected or detected) at Week 4 and \<25 IU/mL (undetected) at Week 8.
Time frame: Week 4 and Week 8
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO
The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment (EoT) when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Time frame: End of treatment, up to 48 weeks
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES
The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
Time frame: End of treatment, up to 48 weeks
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Placebo to BI201335 for 24 weeks
1220.7.0091 Boehringer Ingelheim Investigational Site
North Little Rock, Arkansas, United States
1220.7.0082 Boehringer Ingelheim Investigational Site
Englewood, Colorado, United States
1220.7.0095 Boehringer Ingelheim Investigational Site
Palm Harbor, Florida, United States
1220.7.0039 Boehringer Ingelheim Investigational Site
Columbus, Georgia, United States
1220.7.0013 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
1220.7.0062 Boehringer Ingelheim Investigational Site
Vaiparaiso, Indiana, United States
1220.7.0085 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana, United States
1220.7.0087 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana, United States
1220.7.0101 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States
1220.7.0027 Boehringer Ingelheim Investigational Site
Framingham, Massachusetts, United States
...and 106 more locations
The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Time frame: End of treatment, up to 48 weeks
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES
The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment (EoT) when patients have sustained virological response 12 weeks post treatment. BL=baseline
Time frame: End of treatment, up to 48 weeks
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO
The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Time frame: 12 weeks post treatment, up to 60 weeks
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES
The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
Time frame: 12 weeks post treatment, up to 60 weeks
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO
The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Time frame: 12 weeks post treatment, up to 60 weeks
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES
The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
Time frame: 12 weeks post treatment, up to 60 weeks