A Phase III, randomized, double-blind trial to evaluate the efficacy, safety and tolerability of TMC435 vs. telaprevir, both in combination with PegIFNa-2a and ribavirin, in chronic hepatitis C genotype-1 infectedsubjects who were null or partial responders to prior PegIFNa and ribavirin therapy. - ATTAI

Janssen R&D Ireland0 个研究点目标入组 744 人开始时间: 2012年1月11日最近更新: 2014年11月17日

试验速览

暂无简介。

•- 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 14

•- 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

发起方

Janssen R&D Ireland