A Study of TMC435 in Combination With Peginterferon Alfa-2A and Ribavirin for Hepatitis C Virus Genotype-1 Infected Patients Who Participated in a Control Group of a TMC435 Study

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the efficacy of a treatment with TMC435 in combination with peginterferon alfa-2a and ribavirin in patients who did not clear their hepatitis C infection with peginterferon alfa-2a and ribavirin alone within a previous trial conducted by Tibotec, or who participated in Tibotec trials in which antivirals directed against hepatitis C virus (HCV) were evaluated for short periods of time.

• 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:

• Patients who participated in the placebo arm of a TMC435 study who did not achieve undetectable HCV RNA levels at end of treatment or who relapsed within 1 year after end of treatment OR Patients who received short-term direct-acting antiviral therapy in a Tibotec-sponsored study.

• Liver disease stage documented by liver biopsy is required within 3 years prior to screening unless contraindicated.

Exclusion Criteria:

• Infection with human immunodeficiency virus.

• Liver disease not related to hepatitic C infection.

• Significant laboratory abnormalities or other active diseases.

• Pregnant or planning to become pregnant.

• Prematurely stopped medication in previous TMC435 study for non-compliance or for safety reasons.