Open-Label, Phase 3b Study To Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Genotype 1 Infected, Stable Liver Transplant Subjects - REPLACE

Janssen-Cilag International NV0 个研究点目标入组 74 人开始时间: 2011年11月1日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•- First time liver transplant recipient whose primary pre-transplant diagnosis was chronic hepatitis C genotype 1
•- More than 6 months to 10 years post-liver transplant - Patient did or did not receive treatment for HCV prior to liver transplantation
•- Patient must agree to have a liver graft biopsy within the screening period with exception made if recent serial biopsy with stable stage of hepatic fibrosis
•- A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of ribavirin
•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 8
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Patient is currently infected or co-infected with HCV of another genotype than genotype 1
•- Patient received treatment for hepatitis C following liver transplantation
•- Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
•- Patient has human immunodeficiency virus or hepatitis B virus coinfection
•- Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma or hepatocellular carcinoma)

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