NCT03004625

Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without NS5A RAV

Treatment Efficacy and Safety of 12 Weeks of Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without Baseline NS5A Resistance-associated Variants (DARING)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

A single-arm, multi-center study of HCV-1b patients without baseline non-structure protein (NS5A) resistance-associated variants. Daclatasvir (60mg/day) and asunaprevir (100 mg twice daily) plus weight-based ribavirin (1000-1200 mg/d) for 12 weeks will be prescribed.

Detailed description

Twenty-four weeks of Daclatasvir plus Asunaprevir provided a high treatment efficacy in hepatitis C virus genotype 1b (HCV-1b) patients. Patients with non-structural protein 5A (NS5A) resistance associated variants (RAVs) would have an inferior response. The investigators anticipate that12 weeks of daclatasvir and asunaprevir plus ribavirin is highly effective for HCV Genotype 1b patients without baseline NS5A RAVs.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	daclatasvir	to evaluate the treatment efficacy and safety of the drug in HCV patients
DRUG	asunaprevir	to evaluate the treatment efficacy and safety of the drug in HCV patients
DRUG	Ribavirin	to evaluate the treatment efficacy and safety of the drug in HCV patients

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2016-12-29
• Last updated: 2019-01-09

Locations

1 site across 1 country: Taiwan