NCT03487107

Phase 3 Study of Yimitasvir Phosphate Capsules

A Multicenter, Single-arm, Open-label Study to Investigate the Efficacy and Safety of Yimitasvir Phosphate (DAG181)/Sofosbuvir(SOF) Combination for 12 Weeks in Subjects With Chronic Genotype 1 HCV Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 362 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The safety, tolerability and antiviral activity of DAG181/SOF in treatment-naive and treatment-experienced patients with chronic hepatitis C virus (HCV) genotype 1 infection.

Detailed description

A phase III, multicenter, single-arm, open-label study to assess the safety, tolerability and antiviral activity of DAG181/SOF combination for 12 weeks in adult subjects with chronic genotype 1 HCV infection. Approximately 360 HCV genotype 1 subjects without cirrhosis will be enrolled, treatment-experienced subjects are ≤20%. All subjects will receive DAG181 100 mg/ SOF 400 mg once daily for 12 weeks，with subsequent observation for 24 weeks after cessation of treatment.

Conditions

• Chronic HCV Infection

Interventions

Type	Name	Description
DRUG	SOF	400 mg tablet administered orally once daily
DRUG	DAG181	100 mg capsule administered orally once daily

Timeline

• Start date: 2018-04-17
• Primary completion: 2019-03-28
• Completion: 2019-06-25
• First posted: 2018-04-03
• Last updated: 2020-03-18

Locations

35 sites across 1 country: China