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

NCT ID: NCT02732405

Last Updated: 2016-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-03-31

Brief Summary

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.

Conditions

Hepatitis C; Compensated Cirrhosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MK5172 /MK8742

Group Type: EXPERIMENTAL

MK5172 /MK8742

Intervention Type: DRUG

tablets of MK-5172 100 mg/MK-8742 50 mg will be administered orally, daily for 12 weeks without ribavirin

Interventions

MK5172 /MK8742

tablets of MK-5172 100 mg/MK-8742 50 mg will be administered orally, daily for 12 weeks without ribavirin

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CD Pharma Group S.r.l.

OTHER

Sponsor Role: collaborator

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Savino Bruno, MD

Role: CONTACT

savino.bruno@hunimed.eu

Other Identifiers

2015-004713-24

Identifier Type: -

Identifier Source: org_study_id