Boehringer Ingelheim Pharmaceuticals has begun enrollment at North American sites in its phase III clinical trial program for BI 201335, the company's investigational, oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV). Phase III trials have begun recruiting to evaluate BI 201335 plus standard-of-care (SOC) in both treatment-naive and -experienced patients with chronic genotype-1 HCV, the most challenging HCV genotype to treat.
The FDA has granted Fast Track designation for the development program for BI 201335. Currently, three phase III trials are enrolling patients around the world that, collectively, seek to enroll approximately 1,875 patients. Two of the three trials have U.S. trial sites that plan to enroll approximately 495 patients together.