MedTrace Logo

Efficacy and Safety of Uprifosbuvir (MK-3682) + Ruzasvir (MK-8408) in Treating Hepatitis C Virus Infection Genotypes 1-6 (MK-3682-041)

NCT02956629 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2021-02-02

Study results available
· View outcomes & findings →

Summary

This is a nonrandomized, multi-site, open-label trial to evaluate a novel two-drug combination regimen (uprifosbuvir \[MK-3682\] 450 mg + ruzasvir \[RZR; MK-8408\] 180 mg once daily \[q.d.\] for 12 weeks) in male and female treatment-naïve (TN) or treatment-experienced (TE) participants with chronic hepatitis C virus (HCV) infection genotype (GT) GT1, GT2, GT3, GT4, GT5, or GT6 who have not previously received HCV direct-acting antiviral (DAA) therapy. Cirrhotic (C) and non-cirrhotic (NC) participants with and without human immunodeficiency virus (HIV) co-infection will be enrolled.

Conditions

  • Hepatitis C

Interventions

DRUG

Uprifosbuvir

Participants take 3 tablets each containing 150 mg uprifosbuvir q.d. by mouth.

DRUG

Ruzasvir

Participants take 3 capsules each containing 60 mg RZR q.d. by mouth.

DRUG

Ribavirin

RBV 200 mg capsules will be taken according to package instructions for a maximum of 16 weeks for any GT that meets virologic futility rules on uprifosbuvir + RZR alone.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-16
Primary Completion
2017-12-22
Completion
2018-03-05
FDA Drug
Yes

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02956629 on ClinicalTrials.gov