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

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen R&D Ireland
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Peginterferon alfa-2b; Ribavirin; Simeprevir

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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