Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Hepatitis C

In brief

Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels

Key facts

Study ID

NCT00336479

Run by

Vertex Pharmaceuticals Incorporated

People needed

263

Starts

2006-06-01

Expected to finish

2008-02-01

Last updated by the study team

2014-07-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA
• Have been infected with hepatitis C virus for greater than (>) 6 months
• Seronegative for hepatitis B surface antigen and Human Immunodeficiency Virus 1 and 2
• Must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential)
• Female subjects must have a negative pregnancy test at all visits before the first dose

You may not qualify if…

• Received any approved or investigational drug or drug regimen for the treatment of hepatitis C
• Any medical contraindications to Pegylated Interferon Alfa 2a or Ribavirin therapy
• 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
• Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before study start
• Alcohol abuse or excessive use in the last 12 months
• Participation in any investigational drug study 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

• Call For Information — Phoenix, Arizona, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Stanford University Liver Research — Palo Alto, California, United States
• Call For Information — San Francisco, California, United States
• University of Colorado Hospital — Denver, Colorado, United States
• South Denver Gastroenterology — Englewood, Colorado, United States
• Shands Hospital University of Florida — Gainesville, Florida, United States
• Call for Information — Miami, Florida, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Clarian Hospital — Indianapolis, Indiana, United States
• Gulf Coast Research Associates — Baton Rouge, Louisiana, United States
• Call For Information — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Call for Information — Boston, Massachusetts, United States
• Call For Information — Worcester, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Call For Information — Rochester, Minnesota, United States
• Saint Louis University — St Louis, Missouri, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Call For Information — Manhasset, New York, United States
• Call for Information — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Call For Information — Chapel Hill, North Carolina, United States
• Call For Information — Durham, North Carolina, United States
• University of Cincinnati College of Medicine — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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