Status:
COMPLETED
A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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, Pegas...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
465 Patients enrolled
Trial Details
Trial ID
NCT00420784
Start Date
February 1 2007
End Date
April 1 2009
Last Update
August 5 2014
Active Locations (53)
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1
Birmingham Gastroenterology Associates
Birmingham, Alabama, United States
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
USC
Los Angeles, California, United States
4
Kaiser Permanente Hepatology Research
San Diego, California, United States