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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)

NCT02107365 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-13

No results posted yet for this study

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).

Conditions

  • Hepatitis C Virus Genotype 4 Infection

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

Sponsors & Collaborators

Principal Investigators

  • Dominique ROULOT, MD, PhD · Bobigny University Hospital

  • Eric BELLISSANT, MD, PhD · Rennes University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-02-28
Completion
2015-04-30

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02107365 on ClinicalTrials.gov