A Multicenter, Open Label, Pilot Study to Investigate Tolerability and Efficacy of MK5172 / MK8742 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)

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

Sponsors

Lead sponsor: Istituto Clinico Humanitas

Collaborator: CD Pharma Group S.r.l.

Source Istituto Clinico Humanitas
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.

Overall Status Unknown status
Start Date May 2016
Completion Date March 2017
Primary Completion Date December 2016
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Sustained virologic response rates 12 weeks after discontinuation of therapy (SVR12). SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. 12 weeks after discontinuation of therapy (SVR12).
Enrollment 120
Condition
Intervention

Intervention type: Drug

Intervention name: MK5172 /MK8742

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

Arm group label: MK5172 /MK8742

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Contact

Last name: Savino Bruno, MD

Email: [email protected]

Verification Date

April 2016

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: MK5172 /MK8742

Arm group type: Experimental

Acronym GECOM
Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov