Date: 2011-04-02
Type of information:
phase: 3
Announcement: initiation
Company: Boehringer Ingelheim (Germany)
Product: BI 201335
Action mechanism: oral HCV NS3/4A protease inhibitor
Disease: hepatitis C
Therapeutic area: Infectious diseases
Country: EU Japan USA Canada Taiwan Korea.
Trial details: BI 201335 will be evaluated in multiple randomised, double-blind, placebo-controlled trials in combination with pegylated-interferon and ribavirin (PegIFN/RBV), the current HCV standard of care. The Phase III trials include two studies in treatment- naïve and one study in treatment-experienced chronic genotype-1 HCV patients. The two studies in treatment-naïve patients will be conducted in the European Union and Japan, as well as the U.S., Canada, Taiwan and Korea. The study in treatment-experienced patients will be conducted globally. BI 201335 will be dosed once-daily at either 120mg or 240mg in combination with PegIFN/RBV and treatment durations will range from 24 to 48 weeks. The primary endpoint of each trial is sustained viral response (SVR), which is considered viral cure. These studies are part of a broader Phase III trial programme expected to commence in the second quarter of 2011.
Latest news: Boehringer Ingelheim has announced the study outline for the pivotal Phase III clinical trials designed to evaluate BI 201335, its investigational once-daily oral protease inhibitor, in both treatment-naïve and -experienced patients with chronic genotype-1 hepatitis C virus (HCV). In parallel, the FDA has granted Fast Track designations for BI 201335 plus standard-of care (SOC), and as part of the interferon-free combination with the oral HCV polymerase inhibitor, BI 207127, in chronic genotype-1 HCV patients.
