Overview

An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants

Status:
Completed
Trial end date:
2013-02-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alfa-2a or peginterferon alfa-2b and ribavirin as part of their treatment.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen R&D Ireland
Treatments:
Interferon-alpha
Peginterferon alfa-2a
Peginterferon alfa-2b
Ribavirin
Simeprevir
Criteria
Inclusion Criteria:

- Genotype 1 hepatitis C infection (confirmed at screening)

- Participant has not received any prior treatment for hepatitis C

- Participant must have had a liver biopsy within 3 years before screening (or between
the screening and baseline visit) showing chronic hepatitis C infection

- Must agree to use 2 forms of effective contraception throughout study (both males and
females)

Exclusion Criteria:

- Infection with HIV or non genotype 1 hepatitis C

- Liver disease not related to hepatitic C infection

- Hepatic decompensation

- Significant laboratory abnormalities or other active diseases

- Pregnant or planning to become pregnant