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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Asunaprevir | Small molecule | 200 mg | Oral |
| Subject | Beclabuvir | Small molecule | 75 mg | Oral |
| Subject | Daclatasvir | Small molecule | 30 mg | Oral |