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

• 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 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.

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

Details

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

Criteria

Inclusion Criteria:

• 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)

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