An Efficacy, Pharmacokinetics, Safety and Tolerability Study of TMC435 as Part of a Treatment Regimen for Hepatitis C-Infected Patients

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to provide confirmatory efficacy and safety data of TMC435 as part of a treatment regimen including peginterferon-alpha (PegIFNα-2a) and ribavirin (RBV) in patients with genotype 1 Hepatitis C virus (HCV) infection.

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

Details

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

Criteria

Inclusion Criteria:

• A liver biopsy within 3 years prior to the screening visit (or between screening and day of randomization) with histology consistent with chronic Hepatitis C virus (HCV) infection

• Presence of contraindications for a liver biopsy in patients who are otherwise deemed eligible for participation does not exclude the patient from participation

• Genotype 1 HCV infection (confirmed at screening)

• Plasma HCV RNA of > 10,000 IU/mL at screening

Exclusion Criteria:

• Prior treatment with any approved or investigational drug for the treatment of hepatitis C

• Co-infection with hepatitis B virus or human immunodeficiency virus (HIV)