TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFa-2a and Ribavirin in Chronic Hepatitis C Patients who Were Null or Partial Responders to Prior PegINFa-2a and Ribavirin Therapy

Phase 1

• Conditions: Hepatitis C Virus (HCV) genotype-1 infection; MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-001180-53-BE
• Lead Sponsor: Janssen R&D Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-29
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 744

Inclusion Criteria

- Patient must have had a liver biopsy before screening (or between the screening and baseline visit), unless patient cannot undergo such a procedure (contraindication) or has evidence of portal hypertension due to cirrhosis. For patients who had a liver biopsy performed more than 2 years prior to screening or without a biopsy (because of a contraindication or presence of portal hypertension), a non-invasive staging assessment needs to be available. Non-invasive staging methods, FibroScan, MR-Elastography, or FibroTest/FibroSure, can be used to assess the presence or absence of cirrhosis and must not be
older than 6 months prior to screening
- Documented chronic hepatitis C infection by presence of anti-HCV antibody and/or HCV ribonucleic acid (RNA) at least 6 months prior to screening visit and or/presence of fibrosis on biopsy
- Genotype 1 HCV infection with plasma HCV RNA of >10,000 IU/mL (both confirmed at screening)
- Patient must have had at least 1 documented previous course of treatment with PegINFa-2a or PegINFa-2b in combination with ribavirin (RBV) (at least 12 weeks for null responder and 20 weeks for partial responder)
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 728
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

- Evidence of Hepatic decompensation (impaired functioning of the liver)
- Infection with Human Immunodeficiency Virus (HIV) or non genotype 1 hepatitis C
- Liver disease not related to hepatitis C infection
- Previous chronic hepatitis C treatment, other than PegIFN and RBV

Study & Design

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