The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an
investigational drug, Telaprevir (VX-950) or Placebo, with peginterferon alfa-2a (Pegasys®),
and ribavirin (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 HCV RNA > or = 10,000 IU/mL
- Must have chronic hepatitis C (genotype 1) and have already received at least one
prior course of peginterferon with ribavirin
- Can not also be infected with HIV (AIDS) 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 can not 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).
University Clinic Frankfurt, Department of Internal Medicine, Frankfurt, Germany
Universitatsmedizin Berlin, Berlin, Germany
Leiden University Medical Center, Leiden, Netherlands
Academic Medical Center, Amsterdam, Netherlands
Erasmus MC University Medical Center, Rotterdam, Netherlands
Santurce, Puerto Rico
Birmingham Gastroenterology Associates, Birmingham, Alabama, United States
University of Calgary Medical Clinic - Health Science Centre, Calgary, Alberta T2N 4N1, Canada
Edmonton, Alberta, Canada
BC Hepatitis Program, Vancouver, British Columbia, Canada
Kaiser Permanente Hepatology Research, San Diego, California, United States
USC, Los Angeles, California, United States
University of California San Francisco, San Francisco, California, United States
Cedars-Sinai Medical Center, Los Angeles, California 90048, United States
University of California, San Diego, San Diego, California, United States
University of Colorado Health Sciences Center, Denver, Colorado, United States
Englewood, Colorado, United States
University of Florida, Gainesville, Florida, United States
Miami, Florida, United States
Borland-Groover Clinic, Jacksonville, Florida, United States
Bardenton, Florida, United States
University Hepatitis Center at Bach & Godofsky, Sarasota, Florida, United States
Mayo Clinic Jacksonville, Jacksonville, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Gulf Coast Research, LLC, Baton Rouge, Louisiana, United States
Virology Treatment Center, Maine Medical Center, Portland, Maine, United States
Winnipeg, Manitoba, Canada
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
Omaha, Nebraska, United States
Albuquerque, New Mexico, United States
New York, New York, United States
North Shore University Hospital, Manhasset, New York, United States
Durham, North Carolina, United States
University Internal Medicine Associates, Inc., Cincinnati, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Toronto Western Hospital, Toronto, Ontario, Canada
Toronto, Ontario, Canada
Hershey, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Columbia Gastroenterology Associates, PA, Columbia, South Carolina, United States
Memphis Gastroenterology Group, Germantown, Tennessee, United States
Alamo Medical Research, San Antonio, Texas, United States
Advanced Liver Therapies, Houston, Texas, United States
Liver Institute at Methodist Dallas, Dallas, Texas, United States
Metropolitan Research, Fairfax, Virginia, United States
Richmond, Virginia, United States
Annandale, Virginia, United States
Seattle, Washington, United States
