A Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) in Subjects With Chronic Hepatitis C With Compensated Cirrhosis

Completed · Phase 2

Conditions studied: Chronic Hepatitis C Virus

In brief

The purpose of this study is to evaluate the safety and efficacy of a quadruple regimen (VX-222, telaprevir, pegylated interferon, and ribavirin)in subjects with hepatitis C with cirrhosis.

Key facts

Study ID

NCT01516918

Run by

Vertex Pharmaceuticals Incorporated

People needed

103

Starts

2012-02-01

Expected to finish

2013-12-01

Last updated by the study team

2014-10-20

Who can join

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

You may qualify if…

• Subjects must have genotype 1 Chronic Hepatitis C
• Subjects must have compensated cirrhosis
• Subjects may either be treatment naïve, or may have received a course of Peg IFN/RBV without evidence of response. Subjects who are considered to be relapsers to Peg IFN/RBV, or who are partial or null responders will be considered
• Subjects with hemophilia may be permitted to enroll with permission of the medical monitor

You may not qualify if…

• Any previous treatment with an investigational drug or drug regimen for the treatment of hepatitis C, or previous treatment with an approved protease inhibitor
• Any contraindication to Peg-IFN or RBV therapy
• Evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices
• A history of acquired immunodeficiency infection, organ transplantation or have an ongoing requirement for immunosuppressive medicines

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — San Diego, California, United States
• Study site — Englewood, Colorado, United States
• Study site — Bradenton, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Marietta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Egg Harbor, New Jersey, United States
• Study site — Manhasset, New York, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Asheville, North Carolina, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Providence, Rhode Island, United States
• Study site — Germantown, Tennessee, United States
• Study site — Arlington, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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