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
- Conditions
- Hepatitis C Virus (HCV) genotype-1 infectionMedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-001180-53-SE
- Lead Sponsor
- Janssen R&D Ireland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 744
- 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
- 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
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the non-inferiority of TMC435 versus TVR, both given in combination with PegIFNa-2a and RBV, by less than 12%, with respect to the proportion of subjects with SVR 12 weeks after the planned end of treatment (SVR12).;Secondary Objective: Reference is made to section 2.1 (Objectives), pages 42 and 43 of the Clinical Trial Protocol;Primary end point(s): The proportion of patients with sustained virological response 12 weeks after the planned end of treatment (SVR12);Timepoint(s) of evaluation of this end point: At Week 60
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The proportion of patients with sustained virological response 24 weeks after the planned end of treatment (SVR24);Timepoint(s) of evaluation of this end point: At Week 72