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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT00420784

Run by

Vertex Pharmaceuticals Incorporated

People needed

465

Starts

2007-02-01

Expected to finish

2009-04-01

Last updated by the study team

2014-08-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• USC — Los Angeles, California, United States
• Kaiser Permanente Hepatology Research — San Diego, California, United States
• University of California, San Diego — San Diego, California, United States
• University of California San Francisco — San Francisco, California, United States
• University of Colorado Health Sciences Center — Denver, Colorado, United States
• Study site — Englewood, Colorado, United States
• Study site — Bardenton, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• University Hepatitis Center at Bach & Godofsky — Sarasota, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Gulf Coast Research, LLC — Baton Rouge, Louisiana, United States
• Virology Treatment Center, Maine Medical Center — Portland, Maine, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Beth Isreal Deaconess Medical Center — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Saint Louis University — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Albuquerque, New Mexico, United States
• Birmingham Gastroenterology Associates — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.