Status:
COMPLETED
A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection
Lead Sponsor:
Janssen-Cilag International NV
Conditions:
Hepatitis C, Chronic
Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy, tolerability, and safety of 12-weeks of treatment with TMC435 plus pegylated interferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) in previously un...
Detailed Description
This is a multicenter, international study where all participants will receive triple therapy with the following 3 medications: TMC435 also referred to as simeprevir (formerly known as TMC435350) whic...
Eligibility Criteria
Inclusion
- treatment-naïve with confirmed chronic Hepatitis C Virus (HCV) infection
- liver biopsy performed within 2 years prior to screening or non-invasive confirmation of the liver disease stage (by transient elastography) performed within 6 months prior to screening
- liver disease stage equivalent to Metavir Score F0-F2 (no fibrosis, or portal fibrosis without or with few septa)
Exclusion
- Participants with advanced liver disease equivalent to Metavir score F3-F4 (bridging fibrosis or cirrhosis), with hepatic decompensation, with any liver disease of non-HCV etiology, and/or with a non-genotype 1 or non-genotype 4 hepatitis C, hepatitis B or HIV co-infection will be excluded from the study
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT01846832
Start Date
September 1 2013
End Date
August 1 2015
Last Update
September 21 2016
Active Locations (20)
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1
Linz, Austria
2
Vienna, Austria
3
Brussels, Belgium
4
Edegem, Belgium