Overview

A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients

Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy and safety of TMC435 compared with placebo in combination with peginterferon alfa-2a (pegIFN alfa-2a) and ribavirin in treatment-naive patients with chronic genotype 1 hepatitis C virus (HCV) infection 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:

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

- Patient has never received treatment for HCV

- Patient 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