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

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 alpha-2a and ribavirin as part of their treatment.

Key facts

Study ID

NCT01289782

Run by

Janssen R&D Ireland

People needed

395

Starts

2011-02-01

Expected to finish

2013-01-01

Last updated by the study team

2014-06-04

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)
• Patient has not received any prior treatment for hepatitis C
• Patient 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 — Hoover, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Bakersfield, California, United States
• Study site — Coronado, California, United States
• Study site — Long Beach, California, United States
• Study site — San Diego, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Englewood, Colorado, United States
• Study site — Miami, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Jackson, Mississippi, United States
• Study site — Tupelo, Mississippi, United States
• Study site — St Louis, Missouri, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Darlinghurst, Australia
• Study site — Fitzroy, Australia
• Study site — Kingswood, Australia
• Study site — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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