Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2
- Conditions
- Hepatitis C, Chronic
- Registration Number
- NCT01728324
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 496
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method SVR12 Rates With Historical Control 12 Week (post-treatment) 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.Comparisons of SVR12 Rates Across Treatment Arms 12 Week (post-treatment) Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.
- Secondary Outcome Measures
Name Time Method SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT. 4 weeks (after End Of Treatment) 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.
SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT. 4 weeks (after End Of Treatment) 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.
Prognostic Value of SVR12 Predicting SVR24 24 Week (post-treatment) The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed.
Related Research Topics
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Trial Locations
- Locations (109)
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
Scroll for more (99 remaining)1241.36.00016 Boehringer Ingelheim Investigational Site🇺🇸North Little Rock, Arkansas, United States