Research Study

A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-3682 With Either MK-8742 or MK-8408 in Subjects With Chronic HCV GT1 and GT2 Infection
Principal Investigator 
Eric M. Yoshida

Overview

Body Locations and Systems 
Hepatitis C
ClinicalTrials.gov# 
NCT02332707
Status 
Closed to Recruitment
Study Start/End 
Jan 1, 2015 to Dec 31, 2017
Locations 
Diamond Health Care Centre, Vancouver General Hospital
Name/Title 
Jo-Ann Ford, Study Coordinator
Phone 
604-875-5705
Email Address 
joann.ford@vch.ca
Purpose of Study 

This is a randomized, three-part, open-label trial of grazoprevir (MK-5172) (100 mg) and MK-3682 (300 mg or 450 mg), with either elbasvir (MK-8742) (50 mg) or MK-8408 (60 mg), and with or without ribavirin (RBV), in treatment-naïve (TN) and treatment-experienced (TE) cirrhotic (C) or non-cirrhotic (NC) hepatitis C virus (HCV) participants with chronic HCV genotype (GT) 1 or GT2 infection. Part A will consist of 8 arms to evaluate the safety of dose combinations. In Part B, participants will take 2 MK-3682B fixed dose combination (FDC) tablets once daily (q.d.) by mouth, with or without twice-daily (b.i.d.) RBV (200 mg capsules; weight-based dosing). Participants who relapse following completion of therapy in Part A will be offered the option of retreatment with 16 weeks of MK-3682B with RBV in Part C (data obtained from Part C will not be used in the analysis of outcome measures).

Eligibility 

Visit ClinicalTrials.gov for more information.

Disclaimer 

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers and email addresses are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician.