Phase 2, Open-Label Study to Investigate the Pharmacokinetics, Efficacy, Safety, and Tolerability of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052) and Ribavirin (RBV) in Patients with Recurrent Chronic Hepatitis C Genotype 1b Infection after Orthotopic Liver Transplantation

Janssen R&D, Ireland0 个研究点目标入组 40 人开始时间: 2013年10月1日最近更新: 2015年10月12日

适应症

试验速览

暂无简介。

•- Liver transplant between 6 months and 10 years prior to the screening visit
•-Hepatitis C virus (HCV) genotype 1 subtype b infection
•- Screening HCV ribose nucleic acid level greater than 10,000 IU per milliliter
•- HCV treatment-naïve participants must not have received post-OLT treatment with any approved or investigational drug for the treatment of HCV
•- Receiving stable immunosuppressant therapy (ie, no change in dose in the last month) with cyclosporine or tacrolimus for more than 3 months prior to the screening visit
•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 38
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•- Evidence of acute or chronic hepatic decompensation after the liver transplantation (including ascites, bleeding varices or hepatic encephalopathy)
•- Any liver disease of non-HCV etiology, including current evidence of graft rejection except the presence of liver steatosis
•- Any other clinically significant disease that in the opinion of the investigator would be exacerbated by the known effects of ribavarin
•- Coinfection with HCV of another genotype than genotype 1b, HIV type 1 or 2 (positive HIV-1 or HIV-2 antibodies test at screening), and hepatitis B virus (hepatitis B surface antigen positive)
•- Multi-organ transplant that included heart, lung, pancreas, or kidney

发起方

Janssen R&D, Ireland