NCT02759315

Efficacy and Safety of Uprifosbuvir (MK-3682) With Ruzasvir (MK-8408) in Adults With Chronic Hepatitis C Genotype 1, 2, 3, 4, 5 or 6 Infection (MK-3682-035)

A Phase II, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-3682 + MK-8408 in Subjects With Chronic HCV Genotype 1, 2, 3, 4, 5 or 6 Infection

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, multi-center trial to evaluate the novel 2-drug regimen of uprifosbuvir (MK-3682) 450 mg and ruzasvir (MK-8408) 60 mg in participants with chronic hepatitis C virus (HCV) genotype (GT)1, GT2, GT3, GT4, GT5, or GT6 infection. The impact of the study treatment regimen on the percentage of participants with undetectable HCV ribonucleic acid \[RNA\] 12 weeks after completing study treatment (SVR12) will be evaluated.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Uprifosbuvir 450 mg	450 mg administered as 3 x 150 mg oral tablets
DRUG	Ruzasvir 60 mg	60 mg administered as 6 x 10 mg oral capsules

Timeline

• Start date: 2016-05-03
• Primary completion: 2017-07-27
• Completion: 2017-11-16
• First posted: 2016-05-03
• Last updated: 2019-06-26
• Results posted: 2018-08-06

Regulatory

• FDA-regulated drug study