Chronic HCV Infection Clinical Trial
Official title:
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
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.
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.
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