drugset / Trial / NCT03143998

Efficacy and Safety of Elbasvir/Grazoprevir in Brazilian Participants With Chronic Hepatitis C Virus (HCV) Genotype 1 Infection With Advanced Fibrosis (F3 and F4)

NCT03143998

Phase 4 Withdrawn Merck Sharp & Dohme LLC
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a non-randomized, open-label study of a fixed dose combination (FDC) of elbasvir (50 mg) and grazoprevir (100 mg) (EBR/GZR or MK-5172A) in participants with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection with advanced fibrosis with and without human immunodeficiency virus (HIV) co-infection. All participants will be either HCV treatment naïve (TN) or treatment experienced (TE).

Timeline

Start
2018-02-12
Primary completion
2019-01-12
Completion
2019-01-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Elbasvir Small molecule 50 mg Oral
Subject GRAZOPREVIR ANHYDROUS Small molecule 100 mg Oral