Vertex to Initiate Phase III Study of Hepatitis Drug

Posted on: Wednesday, 20 August 2008, 12:00 CDT Vertex Pharmaceuticals has reached an agreement with the US and EU regulatory authorities to proceed with the Realize trial, a pivotal Phase III clinical trial with the hepatitis C virus protease inhibitor telaprevir in combination therapy for patients with chronic HCV infection who failed to achieve a sustained viral response with prior therapy. The trial will be conducted in the US and EU and will enroll approximately 650 genotype 1 hepatitis C virus (HCV) patients who failed prior treatment with pegylated-interferon (peg-IFN) and ribavirin (RBV). The trial is designed to evaluate two 48-week telaprevir-based regimens in comparison with a 48-week control arm. Telaprevir will be dosed for 12 weeks. The primary endpoint of the trial is sustained viral response (SVR), defined as... [read full story]