A Study of TMC435 plus Pegylated Interferon alfa-2a and Ribavirin in Participants with Chronic HCV Infectio

Phase 1

• Conditions: Hepatitis C Virus (HCV) genotype-1 infection; MedDRA version: 17.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-004905-29-GB
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-08
• Study Completion: 2015-08-31
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 230

Inclusion Criteria

- treatment-naïve with confirmed chronic Hepatitis C Virus (HCV)
infection
- liver biopsy performed within 2 years prior to screening or noninvasive
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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 219
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Primary end point(s): The proportion (percentage) of participants infected with genotype 1<br> HCV with sustained virologic response 12 weeks after planned end of<br> treatment (SVR12)<br> ;Timepoint(s) of evaluation of this end point: Week 24;<br> Secondary Objective: See section 2.1 - Objectives - Major Secondary Objectives, p44 of the<br> Clinical Trial Protocol<br> ;<br> Main Objective: - To determine the efficacy of TMC435 plus PegIFNalfa-2a and RBV when administered for 12 weeks in treatment-naïve subjects with chronic genotype 1 HCV infection, as measured by the proportion of subjects with sustained virologic response 12 weeks after planned end of treatment (SVR12).<br> - To assess the safety and tolerability of TMC435 plus PegIFNalfa-2a and RBV when administered for 12 weeks in treatment-naïve subjects with the chronic genotype 1 HCV infection<br>