Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT02107365
PHASE2

Therapy With Asunaprevir, Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a in HCV Genotype 4-infected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin (ANRS HC32 QUATTRO)

Sponsor: ANRS, Emerging Infectious Diseases

View on ClinicalTrials.gov

Summary

Success rates, after retreatment with Peg-Interferon/Ribavirin bitherapy, in patients infected with HCV (hepatitis C virus) genotype 4 and non-responders to a first standard treatment, are disappointing. The association of Asunaprevir and Daclatasvir in combination with the standard-of-care bitherapy has been shown to increase the efficacy of the treatment in non-responders genotype 1-infected patients. Given the absence of current solutions and urgent therapeutic needs for HCV genotype 4-infected patients previously treated with pegylated Interferon/Ribavirin, this pilot study aims to evaluate the efficacy and safety of a quadritherapy associating Asunaprevir, Daclatasvir, pegylated Interferon alpha-2a and Ribavirin, in this very difficult to treat population. 60 subjects will be enrolled. The primary endpoint will be the rate of sustained virological response (SVR), defined by an undetectable HCV RNA, at Week 36 (12 weeks after the end of a 24 weeks quadritherapy).

Official title: Pilot Study to Assess Efficacy and Safety of a Quadruple Therapy With Asunaprevir, Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a in HCV Genotype 4-infected Patients Non-responders to Pegylated Interferon-Ribavirin Regimen

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2013-11

Completion Date

2015-04

Last Updated

2026-04-13

Healthy Volunteers

No

Interventions

DRUG

Asunaprevir

Asunaprevir 100 mg, 1 capsule twice a day from Day 0 to Week 24

DRUG

Daclatasvir

Daclatasvir 60 mg, 1 tablet once a day from Day 0 to Week 24

DRUG

Ribavirin

Ribavirin tablets or capsules 200 mg, weight-based daily dose ( \<75 kg : 1000 mg ; ≥ 75 kg : 1200 mg), from Day 0 to Week 24

DRUG

Pegylated Interferon alpha-2a

Pegylated Interferon alpha-2a, by subcutaneous injection 180µg / week, from Day 0 to Week 24

Locations (25)

Hôpital AVICENNE

Bobigny, France

Hôpital Jean Verdier

Bondy, France

Hôpital de Haut Lévêque

Bordeaux Pessac, France

Hôpital Beaujon

Clichy, France

Centre Hospitalier Intercommunal

Créteil, France

Hôpital Henri Mondor

Créteil, France

Hôpital Albert Michallon

Grenoble, France

Hôpital Claude Huriez

Lille, France

Hôpital Dupuytren

Limoges, France

Hôpital de la Croix Rousse

Lyon, France

Fondation Hôpital Saint Joseph

Marseille, France

Hôpital Saint Eloi

Montpellier, France

Hôpital de Brabois

Nancy, France

Hôpital de l'Hôtel Dieu

Nantes, France

Hôpital de l'Archet

Nice, France

Hôpital de La Source

Orléans, France

Hôpital Saint Antoine

Paris, France

Hôpital Pitié Salpêtrière

Paris, France

Hôpital Cochin

Paris, France

Hôpital Tenon

Paris, France

Hôpital Pontchaillou

Rennes, France

Hôpital Charles Nicolle

Rouen, France

Institut Arnault Tzank

Saint-Laurent-du-Var, France

Hôpital Purpan

Toulouse, France

Hôpital Paul Brousse

Villejuif, France