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Home » Tibotec launches two phase III trials of TMC435

Tibotec launches two phase III trials of TMC435

March 7, 2011
CenterWatch Staff

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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