Study to Investigate Tolerability and Efficacy of MK5172 / MK8742 Without Ribavirin for 12 Weeks in Patients With Chronic HCV G1b Infection With Compensated Cirrhosis (GECOM)

Istituto Clinico Humanitas

Status and phase: Unknown; Phase 3

Conditions: Hepatitis C; Compensated Cirrhosis

Treatments: Drug: MK5172 /MK8742

Study type: Interventional

Funder types: Other

Identifiers

NCT02732405

2015-004713-24

Details and patient eligibility

About

To assess efficacy (SVR rate) of MK5172 / MK8742 for 12 weeks without RBV in G1b patients with compensated cirrhosis (Child-Pugh A5 to A6) previously failing first gen. PI or non responders to PR.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 (transient elastography (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.

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/μl,
11. Concomitant participation in any clinical trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

MK5172 /MK8742

Experimental group

Treatment:

Drug: MK5172 /MK8742