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Tibotec launches two phase III trials of TMC435

Monday, March 7, 2011 07:38 AM

Tibotec Pharmaceuticals is recruiting patients for two global, phase III, double-blind, randomized trials to examine TMC435, its investigational hepatitis C protease inhibitor, in treatment-naive adults with chronic genotype 1 hepatitis C virus (HCV). A third global phase III trial is being conducted in genotype 1 HCV patients who have experienced a viral relapse after prior interferon-based treatment.

The first trial will evaluate a single TMC435 once-daily oral tablet (150 mg) versus placebo in treatment-naive HCV patients. Both groups will also receive peginterferon alfa-2a (PegasysR) and ribavirin (CopegusR) as part of their treatment. The second trial also will evaluate a single TMC435 once-daily oral tablet (150 mg) versus placebo in treatment-naive HCV patients. However, patients in this trial will either receive peginterferon alfa-2a (PegasysR) and ribavirin (CopegusR) or peginterferon alfa-2b (PegIntronR) and ribavirin (RebetolR) as part of their treatment.

A third trial will evaluate a single TMC435 once-daily oral tablet (150 mg) verses placebo in HCV patients who experienced viral relapse after previous interferon-based therapy. Both groups will receive peginterferon alfa-2a (PegasysR) and ribavirin (CopegusR). The complete treatment duration for all three trials will be 24 or 48 weeks.

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