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
Conditions
Sponsors
Janssen R&D Ireland
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Norway, Poland, Portugal, Romania, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactJanssen Biologics BV
Janssen-Cilag International NV - Clinical Registry Group
Outcome results
None listed