A Study of TMC435 in Combination With Peginterferon Alfa-2A and Ribavirin for Hepatitis C Virus Genotype-1 Infected Patients Who Participated in a Control Group of a TMC435 Study

Completed · Phase 3

Conditions studied: Hepatitis C

In brief

The purpose of this study is to investigate the efficacy of a treatment with TMC435 in combination with peginterferon alfa-2a and ribavirin in patients who did not clear their hepatitis C infection with peginterferon alfa-2a and ribavirin alone within a previous trial conducted by Tibotec, or who participated in Tibotec trials in which antivirals directed against hepatitis C virus (HCV) were evaluated for short periods of time.

Key facts

Study ID

NCT01323244

Run by

Janssen R&D Ireland

People needed

142

Starts

2011-12-01

Expected to finish

2015-03-01

Last updated by the study team

2016-04-04

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who participated in the placebo arm of a TMC435 study who did not achieve undetectable HCV RNA levels at end of treatment or who relapsed within 1 year after end of treatment OR Patients who received short-term direct-acting antiviral therapy in a Tibotec-sponsored study.
• Liver disease stage documented by liver biopsy is required within 3 years prior to screening unless contraindicated.

You may not qualify if…

• Infection with human immunodeficiency virus.
• Liver disease not related to hepatitic C infection.
• Significant laboratory abnormalities or other active diseases.
• Pregnant or planning to become pregnant.
• Prematurely stopped medication in previous TMC435 study for non-compliance or for safety reasons.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Englewood, Colorado, United States
• Study site — Jacksonville, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Jackson, Mississippi, United States
• Study site — Tupelo, Mississippi, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Buenos Aires, Argentina
• Study site — Rosario, Santa Fe, Argentina
• Study site — Adelaide, Australia
• Study site — Concord, Australia
• Study site — Melbourne, Australia
• Study site — Wentworthville, Australia
• Study site — Woolloongabba, Australia
• Study site — Vienna, Austria
• Study site — Antwerp, Belgium
• Study site — Brussels, Belgium
• Study site — Bakersfield, California, United States

Full record on ClinicalTrials.gov

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