Overview

A Study of TMC435 in Genotype 1, Hepatitis C-infected Patients Who Relapsed After Previous Interferon (IFN)-Based Therapy

Status:
Completed
Trial end date:
2012-08-01
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 relapsed after previous interferon (IFN)-based therapy in Japan.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Pharmaceutical K.K.
Treatments:
Interferons
Peginterferon alfa-2a
Ribavirin
Simeprevir
Criteria
Inclusion Criteria:

- Participants must have chronic genotype 1 HCV with HCV RNA level >= 5.0 log10 IU/mL

- Participant relapsed after 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 pegIFN or ribavirin therapy

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