Chronic HCV Infection Clinical Trial
Official title:
A Multicenter, Randomized, Parallel Assigned, 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 2, multicenter, randomized, parallel Assigned, open-label study to explore the
safety, tolerability and antiviral activity of DAG181/SOF combination for 12 weeks in adult
subjects with chronic genotype 1 HCV infection.
Approximately 120 HCV genotype 1 subjects without cirrhosis will be enrolled,
treatment-experienced subjects are ≤20%, all subjects will be randomized (1:1) to one of the
following two treatment groups by IWRS (Medidata Balance): a) DAG181 100 mg/ SOF 400 mg once
daily for 12 weeks, b) DAG181 200 mg/ SOF 400 mg once daily for 12 weeks. Randomization will
be stratified by "treatment-naive" or "treatment-experienced".
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