MedTrace Logo

Efficacy and Safety of Grazoprevir (+) Uprifosbuvir (+) Ruzasvir (MK-3682B) (MK-5172 + MK-3682 + MK-8408) Fixed Dose Combination in Chronic HCV Participants Failing Prior Antiviral Treatment (MK-3682-021)

NCT02613403 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2024-05-22

Study results available
· View outcomes & findings →

Summary

This is a randomized, multicenter, 2-part, open-label trial of the combination regimen of grazoprevir (GZR \[MK-5172\]; 100mg), uprifosbuvir (UPR \[MK-3682\]; 450 mg) and ruzasvir (RZR \[MK-8408\]; 60 mg) with and without Ribavirin (RBV) in cirrhotic (C) or non-cirrhotic (NC) participants infected with hepatitis C virus (HCV) previously failing a direct-acting antiviral regimen (DAA). The combination regimen, referred to as MK-3682B, will be administered as two fixed-dose combination (FDC) tablets, given once-daily. The study will evaluate the efficacy of MK-3682B with or without RBV as assessed by the proportion of participants achieving Sustained Virologic Response 12 weeks (SVR12) after the end of all study therapy.

Conditions

  • Hepatitis
  • Hepatitis C
  • Digestive System Diseases
  • Flaviviridae Infections
  • Hepatitis, Viral, Human
  • Liver Diseases
  • RNA Virus Infections
  • Virus Diseases

Interventions

DRUG

MK-3682B

Two MK- 3682B 1,136 mg FDC tablets each containing 50 mg MK-5172 (GZR), 225 mg MK-3682 (UPR, formerly IDX21437), and 30 mg MK-8408 (RZR) taken once daily by mouth.

DRUG

Ribavirin

Ribavirin 200 mg capsules, taken twice daily by mouth as part of a weight-based dosing regimen. Depending on participant body weight, total daily dose of Ribavirin may be 800, 1000, 1200 or 1400 mg per day.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-10
Primary Completion
2017-01-09
Completion
2017-03-27
FDA Drug
Yes

More Related Trials

Entities

Diseases
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 NCT02613403 on ClinicalTrials.gov