Tibotec Begins Enrollment for Phase III Study of Telaprevir, an Investigational Agent, in HCV Patients Who Failed Prior Treatment
15.10.2008 16:05 Political Press Releases
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To: MEDICAL EDITORS
Contact: Karen Manson of Tibotec BVBA, Mobile: +32 (479) 89 47 99
REALIZE is the first phase III study to evaluate a specifically targeted antiviral therapy for hepatitis C (STAT-C) across a full range of HCV-patients who failed prior treatment to current standard of care, including null responders
MECHELEN, Belgium, Oct. 15 /PRNewswire-USNewswire/ -- Tibotec BVBA announced today that it has begun enrolling patients in its phase III clinical trial evaluating telaprevir, an investigational hepatitis C virus protease inhibitor, in patients who failed prior therapy with peginterferon (Peg-IFN) plus ribavarin (RBV). The trial, known as REALIZE, will compare the efficacy, safety and tolerability of telaprevir combined with Peg-IFN plus RBV versus Peg-IFN and RBV alone, the current standard of care. Investigators at U.S. trial centers have begun screening patients for participation in the study, with global centers expected to begin screening in the coming weeks. Telaprevir is being co-developed by Vertex Pharmaceuticals Incorporated and Tibotec. Tibotec, the sponsor of the REALIZE trial, is managing the trial worldwide.
"We are excited about the ongoing development of telaprevir, potentially the first direct antiviral for the treatment of HCV, which may provide a new option for patients who have failed the current standard of care," said Roger Pomerantz, MD, President, Tibotec Research and Development. "We are committed to examining the safety and efficacy of telaprevir through phase III trials and look forward to working with health authorities with the goal of making this therapy available to HCV infected patients."
The REALIZE trial (Re-treatment of Patients with Telaprevir-based Regimen to Optimize Outcomes) is a phase III, randomized, placebo-controlled double-blind study conducted over 72 weeks to examine two regimens of 750 mg telaprevir every eight hours (with and without a delayed start) combined with Peg-IFN and RBV versus Peg-IFN and RBV alone. To be eligible for the study, patients must belong to one of the following three groups:
1. Null responders (defined as patients who achieved
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