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

A Phase 2 Study of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Subjects With Genotype 1 Hepatitis C Who Have Not Achieved Sustained Viral Response With a Prior Course of Interferon Based Therapy

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.

Inclusion Criteria:

• Males and females between 18 and 70 years old
• Detectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) greater than or equal to (>=) 10,000 international units per milliliter (IU/mL)
• Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of pegylated interferon alfa 2a with ribavirin
• Cannot also be infected with Human Immunodeficiency Virus or hepatitis B
• Must be judged to be in general good health and able to receive Pegasys® and Copegus®
• No drug or alcohol abuse in the last year
• Must agree to use two effective methods of birth control during the study and for 6 months after you stop taking study medication. One of the methods needs to be a 'barrier' method (condom or diaphragm)
• If you are a woman, you cannot be in this study if you are pregnant or nursing

Exclusion Criteria:

• Participation in any clinical trial of a HCV protease inhibitor of any duration
• Prior response to therapy and failure to achieve SVR which was due to treatment non-compliance
• Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis
• Diagnosed or suspected hepatocellular carcinoma
• History of or current evidence of decompensated liver disease
• Participation in any clinical trial of an investigational drug within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study)