A Multicenter, Open Label, Pilot Study to Investigate Tolerability and Efficacy of MK5172 (Grazoprevir) / MK8742 (Elbasvir) Without Ribavirin for 12 Weeks in Patients With Chronic HCV G1b Infection With Compensated Cirrhosis (Child-Pugh A5 to A6) and No Response to PR or Prior Failure to First Generation Protease Inhibitors (PIs).GECOM study - GECOM Study

IRCCS ISTITUTO CLINICO HUMANITAS0 个研究点目标入组 120 人开始时间: 2018年11月30日最近更新: 2022年3月14日

研究概览

暂无简介。

•1.Informed consent form signed,
•2.Age > 18 years,
•3.Chronic infection with Hepatitis C virus genotype 1b,
•4.HCV RNA > 100 IU/mL,
•5.HCV patients previously treated by PR with no response or previously treated with first generation PIs (boceprevir, telaprevir, simeprevir) and failing therapy,
•6.Subjects with compensated cirrhosis with Child-Pugh score ranging between A5 to A6. Cirrhosis defined by liver biopsy (METAVIR F4) or non-invasive methods (transientelastography (FibroScan) > 12.5 KPa; or FibroTest or FibroSure > 0.75 with APRI >2),
•7.Hepatic Venous Pressure Gradient (HVPG) > 6 mmHg (only in selected sites),
•8.Albumin level = 3.0 g/dl,
•9.Platelet count = 75 x 103/µL.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 1
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

•1.Child-Pugh score greater than CP-A6,
•2.Patients with HCV genotype 1a, 2, 3, 4, 5, 6,
•3.Have any serious or active medical illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance,
•4.HIV or chronic hepatitis B virus (HBV) infection (HBsAg positive),
•5.Decompensated cirrhosis/previous decompensation,
•6.Pregnancy,
•7.Breast-feeding,
•8.Known hypersensitivity to Grazoprevir, Elbasvir or any of its components,
•9.Albumin level < 3.0 g/dl,
•10.Platelet count < 75 x 103/?l,
•11.Concomitant participation in any clinical trial.

发起方

IRCCS ISTITUTO CLINICO HUMANITAS