Tibotec begins REALIZE trial enrollment

Tibotec Pharmaceuticals, a division of US health care giant Johnson & Johnson, has begun enrolling patients in its Phase III trial evaluating telaprevir, an investigational hepatitis C virus protease inhibitor, in patients who failed prior therapy with peginterferon plus ribavarin.

The REALIZE trial is a randomized, placebo-controlled, double-blind study conducted over 72 weeks that will compare the efficacy, safety and tolerability of two regimens of 750mg telaprevir every eight hours (with and without a delayed start) combined with peginterferon and ribavarin versus peginterferon and ribavarin alone.

The primary endpoint of the study is sustained virologic response, defined as undetectable HCV RNA (<10 IU/mL) 24 weeks after the completion of treatment. The drug is being co-developed with Austin, Texas-headquartered Vertex Pharmaceuticals.