Overview

Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, With Non-severe Fibrosis

Status:
Completed

Trial end date:
2019-04-01

Target enrollment:

Participant gender:

Summary

A Phase 3, Global, Multicenter, Open-Label Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non-severe fibrosis The primary objectives of this study are as follows: - To evaluate the efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12). - To evaluate the safety and tolerability of EBV/GZR treatment The secondary objectives of this study are as follows: - To determine the proportion of subjects who attain SVR at 4 and 24 weeks after cessation of treatment (SVR4 and SVR24) - To evaluate the proportion of subjects with virologic failure - To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of treatment. - To evaluate the emergence of viral resistance to EBV/GZR during treatment and after cessation of treatment

Phase:

Phase 3

Details

Lead Sponsor:

University Hospital, Clermont-Ferrand

Collaborators:

LC2 PHARMA
Merck Sharp & Dohme Corp.

Treatments:

Grazoprevir