An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy

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 patients who are infected with genotype 1 hepatitis C virus who relapsed after previous interferon-based therapy. Patients will also receive peginterferon alfa-2a and ribavirin as part of their treatment.

Key facts

Study ID

NCT01281839

Run by

Janssen R&D Ireland

People needed

394

Starts

2011-02-01

Expected to finish

2013-02-01

Last updated by the study team

2014-04-23

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)
• Have previously received peginterferon-based therapy for at least 24 weeks with documented HCV RNA at last measurement and relapsed within 1 year of last taking medication
• 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 — Aurora, Colorado, United States
• 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 — Saint Paul, Minnesota, United States
• Study site — Jackson, Mississippi, United States
• Study site — Germantown, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Adelaide, Australia
• Study site — Kingswood, Australia
• Study site — Melbourne, Australia
• Study site — Sydney, Australia
• Study site — Woolloongabba, Australia
• 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 — Vancouver, British Columbia, Canada
• Study site — Ottawa, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Bakersfield, California, United States

Full record on ClinicalTrials.gov

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