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

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

Conditions

• Chronic HCV Infection

Interventions

DRUG

Elbasvir/Grazoprevir Fixed Dose Combination

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).

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• University Hospital, Clermont-Ferrand

  lead OTHER

Principal Investigators

• Armand ABERGEL · University Hospital, Clermont-Ferrand

• Isabelle FOUCHART-HUBERT · University Hospital, Angers

• Vincent DI MARTINO · Centre Hospitalier Universitaire de Besancon

• Véronique LOUSTAUD RATTI · CHU LIMOGES

• Jérôme GOURNAY · Nantes University Hospital

• Tarik ASSELAH · Hôpital Beaujon

• Didier SAMUEL · Hôpital Paul Brousse

• Dominique LARREY · University Hospital, Montpellier

• Sophie METIVIER · CHU Toulouse Hopital Purpan

• Christophe HEZODE · CHU Henri Mondor

• Albert TRAN · CHU Nice hopital Archet II

• François BAILLY · Hospice civils de Lyon, hopital de la croix Rousse

• Stanislas POL · AP-HP Hopital Cochin

• Valérie CANVA · CHU de Lille

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-11

Primary Completion

2018-11-10

Completion

2019-04-30

Countries

• France

Study Locations