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A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT00420784•Vertex Pharmaceuticals Incorporated

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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)

Locations (53)

Birmingham Gastroenterology Associates

Birmingham, Alabama, United States

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

Englewood, Colorado, United States

Bardenton, Florida, United States

University of Florida

Gainesville, Florida, United States

Key Dates

Start Date

February 1, 2007

Primary Completion Date

December 1, 2008

Completion Date

April 1, 2009

Last Updated

August 5, 2014

Enrollment

465

ACTUAL participants

Conditions

Hepatitis C

Interventions

Telaprevir

DRUG

Ribavirin

DRUG

Pegylated Interferon Alfa 2a

DRUG

Matching Placebo

DRUG

Implementing Low-Barrier HCV Treatment in a Jail Setting

NCT06953479

HEPATITIS C (HCV)Incarceration+2 more

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RECRUITINGNA

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

NCT03135886

HIV/AIDSHepatitis C+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 5, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Implementing Low-Barrier HCV Treatment in a Jail Setting

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