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".
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
129
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Percentage of subjects with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment
Time frame: Posttreatment Week 12
Safety and tolerability were evaluated based on adverse event monitoring, laboratory tests, 12-lead ECG assessments, vital signs measurements and physical examinations.
Time frame: Up to posttreatment week 24
Percentage of subjects with sustained virologic response 4, 8 and 24 weeks after discontinuation of therapy (SVR4,SVR8 and SVR24)
SVR4,SVR8 and SVR24 were defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 4, 8 and 24 weeks after stopping study treatment, respectively.
Time frame: Posttreatment Weeks 4,8 and 24
Percentage of subjects with HCV RNA < the lower limit of quantitation (LLOQ) while on treatment
Time frame: Baseline to week 12
The time to first achieve "HCV RNA < the lower limit of quantitation (LLOQ)" while on treatment
Time frame: Baseline to week 12
HCV RNA change from baseline
Time frame: Up to posttreatment week 24
Percentage of subjects with virologic failure
Virologic failure was defined as: 1. On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥the lower limit of quantitation (LLOQ) after having previously had HCV RNA \<the lower limit of quantitation (LLOQ) while on treatment), or Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥the lower limit of quantitation (LLOQ) through 8 weeks of treatment); 2. Virologic relapse: Confirmed HCV RNA ≥the lower limit of quantitation (LLOQ) during the posttreatment period having achieved HCV RNA \<the lower limit of quantitation (LLOQ) at last on-treatment visit.
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Beijing YouAn Hospital,Capital Medical University
Beijing, Beijing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Hainan General Hospital
Haikou, Hainan, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University Science & Technology
Wuhan, Hubei, China
...and 7 more locations
Time frame: Up to posttreatment week 24
Viral resistance
Viral resistance to DAG181 and/or SOF during treatment and after cessation of treatment
Time frame: Up to posttreatment week 24