drugset / Trial / NCT00420784

A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)

NCT00420784

Phase 2 Completed 465 enrolled Vertex Pharmaceuticals Incorporated
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy.

Timeline

Start
2007-02
Primary completion
2008-12
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Telaprevir Small molecule 750 mg Oral
Background Peginterferon alfa-2a Protein / enzyme biologic 180 ug Subcutaneous
Background Ribavirin Small molecule 1000 mg Oral
Background Ribavirin Small molecule 1200 mg Oral