A Phase III Study of TMC435 in Genotype 1, Hepatitis C-infected Participants Who Failed to Respond to Previous IFN-based Therapy

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus (HCV)-infected participants who failed to respond to previous interferon (IFN)-based therapy in Japan.

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

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Ribavirin; Simeprevir

Criteria

Inclusion Criteria:

• Participant must have chronic genotype 1 HCV infection with HCV RNA level >= 5.0 log10 IU/mL

• Participant failed to respond to previous IFN-based therapy

• Participant must be willing to use contraceptive measures from the time of informed consent to 6 months after last dose of study medication.

Exclusion Criteria:

• Co-infection with any other HCV genotype or co-infection with the human immunodeficiency virus (HIV)

• Diagnosed with hepatic cirrhosis or hepatic failure

• A medical condition which is a contraindication to PegIFNα-2a or ribavirin therapy

• History of, or any current medical condition which could impact the safety of the patient in the study