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news.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.
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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 undetectable HCV RNA 24 weeks after the completion of treatment.
Patients in all treatment arms will be followed for 24 weeks after completion of treatment to assess SVR.
Tibotec expects to complete enrollment of the Realize trial in the first quarter of 2009.