drugset / Trial / NCT02309450

Pilot Study to Assess Efficacy and Safety of a Triple Therapy With Asunaprevir, Daclatasvir, and BMS-791325 in HCV Genotype 4-infected Patients After Failure of Pegylated Interferon-Ribavirin Regimen

NCT02309450

NaSingle-groupOpen-labelTreatment

Summary

ANRS HC 33 is a pilot study to assess efficacy and safety of a DCV 3DAA therapy with Asunaprevir, Daclatasvir and BMS-791325 in HCV genotype 4-infected patients after failure of pegylated Interferon-Ribavirin regimen. Proportion of patients with cirrhosis will be limited to 50% of all patients included, cirrhosis being defined as a METAVIR score of F4 on the liver biopsy or an hepatic impulse elastometry ≥ 14 kPa or a Fibrotest® result \> 0,75.

Timeline

Start
2014-12
Primary completion
2015-11
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Asunaprevir Small molecule 200 mg Oral
Subject Beclabuvir Small molecule 75 mg Oral
Subject Daclatasvir Small molecule 30 mg Oral