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

NCT02732405 | Unknown Phase 3

• 1 other identifier: 2015-004713-24
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (1)

MK5172 /MK8742

EXPERIMENTAL

Drug: MK5172 /MK8742

Interventions

MK5172 /MK8742 DRUG

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

MK5172 /MK8742

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent form signed,
• Age \> 18 years,
• Chronic infection with Hepatitis C virus genotype 1b,
• HCV RNA \> 100 IU/mL,
• HCV patients previously treated by PR with no response or previously treated with first generation PIs (boceprevir, telaprevir, simeprevir) and failing therapy,
• 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),
• Hepatic Venous Pressure Gradient (HVPG) \> 6 mmHg (only in selected sites),
• Albumin level ≥ 3.0 g/dl,
• Platelet count ≥ 75 x 103/μL.

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• CD Pharma Group S.r.l.: collaborator

MeSH Terms

Conditions

Hepatitis C

Interventions

grazoprevir; elbasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Central Study Contacts

Savino Bruno, MD

CONTACT

savino.bruno@hunimed.eu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: April 8, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 8, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share