VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo

Completed · Phase 3

Conditions studied: Hepatitis C, Chronic

In brief

The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and tolerability of telaprevir in combination with standard treatment will be evaluated.

Key facts

Study ID

NCT01054573

Run by

Janssen Infectious Diseases BVBA

People needed

90

Starts

2010-04-01

Expected to finish

2012-05-01

Last updated by the study team

2013-05-08

Who can join

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

You may qualify if…

• Patient from the control group of the C216 study who failed therapy for virologic reasons
• Patient must have completed all assessments in the C216 trial
• 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 received any direct acting anti-viral HCV therapy after discontinuation of the C216 trial
• Patient has history of decompensated liver disease
• Patient has history of acute or chronic pancreatitis
• Patient has condition that requires use of systemic corticosteroids
• Patient who prematurely stopped medication for non-compliance or for whom it would be unsafe to repeat treatment
• Patient has history of decompensated liver disease or history of cirrhosis with hepatocellular carcinoma

Where it is running

• Study site — Coronado, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — Bradenton, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Kansas City, Missouri, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Columbia, South Carolina, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Adelaide, Australia
• Study site — Clayton, Australia
• Study site — Darlinghurst, Australia
• Study site — Perth, Australia
• Study site — Brussels, Belgium
• Study site — Ghent, Belgium
• Study site — Leuven, Belgium
• Study site — Distrito Barao Geraldo-Campina, Brazil
• Study site — Salvador, Brazil
• Study site — São Paulo, Brazil
• Study site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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