The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
496
8 weeks of placebo treatment
24 weeks of active treatment
24 weeks of active treatment
SVR12 Rates With Historical Control
Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level \<25 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. The number of participants analyzed are actually adjusted number of participant analyzed.
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: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT.
Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level \<25 IU/mL at 4 weeks after EOT.
Time frame: 4 weeks (after End Of Treatment)
SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT.
Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level \<25 IU/mL at 24 weeks after EOT.
Time frame: 4 weeks (after End Of Treatment)
Prognostic Value of SVR12 Predicting SVR24
The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed.
Time frame: 24 Week (post-treatment)
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24 weeks of active treatment
24 weeks of active treatment
8 weeks of placebo treatment
24 weeks of active treatment
8 weeks of placebo treatment
16 weeks of active treatment
16 weeks of active treatment
24 weeks of active treatment
16 weeks of active treatment
1241.36.00016 Boehringer Ingelheim Investigational Site
North Little Rock, Arkansas, United States
1241.36.00020 Boehringer Ingelheim Investigational Site
Anaheim, California, United States
1241.36.00005 Boehringer Ingelheim Investigational Site
Bakersfield, California, United States
1241.36.00009 Boehringer Ingelheim Investigational Site
La Jolla, California, United States
1241.36.00007 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1241.36.00013 Boehringer Ingelheim Investigational Site
Oceanside, California, United States
1241.36.00019 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1241.36.00034 Boehringer Ingelheim Investigational Site
San Francisco, California, United States
1241.36.00022 Boehringer Ingelheim Investigational Site
Bradenton, Florida, United States
1241.36.00004 Boehringer Ingelheim Investigational Site
DeLand, Florida, United States
...and 99 more locations