Hepatitis C Virus Genotype 4 Infection Clinical Trial
Official title:
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
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.
The clinical trial is multi-centre, national, Phase 2, open-label, single-arm. The primary
objective of this study is to assess, in HCV genotype 4-infected patients in failure to
prior treatment with pegylated Interferon and Ribavirin bitherapy, the rate of sustained
virological response (SVR) 12 weeks after 12 weeks of treatment with an all-oral combination
of 3 DAAs in a Fixed-Dose-Combination (Asunaprevir 200 mg, Daclatasvir 30 mg and BMS -
791325 75 mg) twice a day.
Estimated enrollment is 60 patients during the enrolment period (9 months).
Schedule of assessments:
w4-w8 : screening D0 : Start of anti-HCV tritherapy (Asunaprevir + Daclatasvir + BMS-791325)
w12: stop tritherapy w24: Sustained virological response SVR12 assessment (12 weeks post
treatment) w36 : Sustained virological response SVR24 assessment (24 weeks post treatment)
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02107365 -
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)
|
Phase 2 |