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COMPLETED
NCT02647632
PHASE2

Study to Assess Efficacy and Safety of Grazoprevir/Elbasvir Associated With Sofosbuvir and Ribavirin in HCV Genotype 1 or 4-infected Patients Who Failed Direct Acting Antivirals (DAA) Bitherapy With Sofosbuvir

Sponsor: ANRS, Emerging Infectious Diseases

View on ClinicalTrials.gov

Summary

The primary objective of this study is to estimate, in HCV genotype 1 or 4-infected patients who failed a prior DAA bitherapy with Sofosbuvir, the efficacy of a treatment with Grazoprevir/Elbasvir, Sofosbuvir and Ribavirin in the two treatment groups and compare the rate of sustained virological response (SVR) 12 weeks after 16 or 24 weeks of this treatment. SVR12 is defined as HCV RNA \< LLOQ (either TD\[u\] or TND).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2016-01

Completion Date

2017-04

Last Updated

2026-06-12

Healthy Volunteers

No

Conditions

Interventions

DRUG

Grazoprevir/Elbasvir

DRUG

Sofosbuvir

DRUG

Ribavirin

Locations (13)

ASSELAH Tarik

Clichy, France

Christophe HEZODE

Créteil, France

LEROY Vincent

Grenoble, France

ZOULIM Fabien

Lyon, France

BOURLIERE Marc

Marseille, France

LARREY Dominique

Montpellier, France

TRAN Albert

Nice, France

SERFATY Lawrence

Paris, France

POL Stanislas

Paris, France

JEZEQUEL Caroline

Rennes, France

ALRIC Laurent

Toulouse, France

METIVIER Sophie

Toulouse, France

SAMUEL Didier

Villejuif, France