A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment

Completed · Phase 3 · Has a placebo group

Conditions studied: Hepatitis C, Chronic

In brief

The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.

Key facts

Study ID

NCT00703118

Run by

Tibotec BVBA

People needed

663

Starts

2008-10-01

Expected to finish

2010-07-01

Last updated by the study team

2014-01-22

Who can join

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

You may qualify if…

• Patient must have chronic hepatitis C infection (genotype 1) with HCV RNA level >= 1000 IU/mL
• Patient must have failed at least 1 prior course of Peg-IFN/RBV therapy (standard treatment)
• Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication

You may not qualify if…

• Patient is a previous non-responder that is classified as a viral breakthrough case
• Patient is infected with Hepatitis C virus, genotype 1, exhibiting more than one subtype
• Patient has Hepatitis C virus, genotype 1, and exhibits co-infection with any other genotype
• Evidence of decompensated liver disease
• Patient has condition that requires use of systemic corticosteroids

Where it is running

• Study site — Coronado, California, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Bradenton, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Plymouth, Minnesota, United States
• Study site — Kansas City, Missouri, United States
• Study site — Egg Harbor Twp, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Manhasset, New York, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Columbia, South Carolina, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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