A Multicenter, Open Label (non randomized), Pilot Study to Investigate Tolerability and Efficacy ( Sustained virologic response rate (SVR)) of the new therapy 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 peginterferon and ribavirin or Prior Failure to First Generation Protease Inhibitors (PIs).

Phase 1

• Conditions: Chronic infection with Hepatitis C virus genotype 1b with compensated cirrhosis; MedDRA version: 20.1Level: LLTClassification code 10064844Term: Compensated cirrhosisSystem Organ Class: 100000004871; MedDRA version: 20.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-004713-24-IT
• Lead Sponsor: IRCCS ISTITUTO CLINICO HUMANITAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-30
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified