An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants

Completed · Phase 3 · Has a placebo group

Conditions studied: Hepatitis C

In brief

The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alfa-2a or peginterferon alfa-2b and ribavirin as part of their treatment.

Key facts

Study ID

NCT01290679

Run by

Janssen R&D Ireland

People needed

393

Starts

2011-03-01

Expected to finish

2013-02-01

Last updated by the study team

2014-06-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Genotype 1 hepatitis C infection (confirmed at screening)
• Participant has not received any prior treatment for hepatitis C
• Participant must have had a liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis C infection
• Must agree to use 2 forms of effective contraception throughout study (both males and females)

You may not qualify if…

• Infection with HIV or non genotype 1 hepatitis C
• Liver disease not related to hepatitic C infection
• Hepatic decompensation
• Significant laboratory abnormalities or other active diseases
• Pregnant or planning to become pregnant

Where it is running

• Study site — Jacksonville, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Crestview Hills, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Germantown, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Falls Church, Virginia, United States
• Study site — Buenos Aires, Argentina
• Study site — Rosario, Santa Fe, Argentina
• Study site — Vienna, Austria
• Study site — Antwerp, Belgium
• Study site — Bruges, Belgium
• Study site — Brussels, Belgium
• Study site — Ghent, Belgium
• Study site — Leuven, Belgium
• Study site — Salvador, Brazil
• Study site — São Paulo, Brazil
• Study site — Plovdiv, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Clichy, France
• Study site — Créteil, France
• Study site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.