The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
470
24 weeks of active RBV
16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335
24 weeks of active RBV
SVR12 Rates With Historical Control
Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C Virus ribonucleic acid (HCV RNA) level \<25 international units/millilitre (IU/mL) at 12 weeks after End of Treatment (EoT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint
Time frame: 12 Week (post-treatment)
Comparisons of SVR12 Rates Across Treatment Arms
Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.
Time frame: 12 Week (post-treatment)
SVR4
Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4).
Time frame: 4 Week (post-treatment)
SVR24
Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24).
Time frame: 24 Week (post-treatment)
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24 weeks of BI 207127
24 weeks of BI 201335
16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin
16 weeks BI 207127 followed by 8 weeks placebo to BI 207127
24 weeks of 201335
24 weeks of BI 207127
1241.20.00026 Boehringer Ingelheim Investigational Site
Dothan, Alabama, United States
1241.20.00033 Boehringer Ingelheim Investigational Site
Chula Vista, California, United States
1241.20.00006 Boehringer Ingelheim Investigational Site
La Mesa, California, United States
1241.20.00003 Boehringer Ingelheim Investigational Site
Oceanside, California, United States
1241.20.00008 Boehringer Ingelheim Investigational Site
Poway, California, United States
1241.20.00015 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
1241.20.00014 Boehringer Ingelheim Investigational Site
Ft. Pierce, Florida, United States
1241.20.00004 Boehringer Ingelheim Investigational Site
Maitland, Florida, United States
1241.20.00010 Boehringer Ingelheim Investigational Site
Decatur, Georgia, United States
1241.20.00001 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States
...and 91 more locations