EU and US regulators approve pivotal Ph III telaprevir trial

USA-based Vertex has reached agreement with US and European regulators to proceed with the REALIZE trial, a pivotal Phase III evaluation of its hepatitis C virus protease inhibitor, telaprevir, as a 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 USA and Europe enrolling approximately 650 genotype-1 HCV patients who failed prior treatment with pegylated-interferon and ribavirin. The study is designed to evaluate two 48-week telaprevir-based regimens in comparison with a 48-week control arm. The agent will be dosed for 12 weeks. The primary endpoint of the trial is SVR, defined as undetectable HCV RNA (<10 IU/mL) 24 weeks after the completion of treatment.