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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
362
Percentage of subjects with sustained virologic response 12 weeks after discontinuation of therapy(SVR12)
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after discontinuation of therapy
Time frame: Posttreatment Week 12
Safety and tolerability were evaluated based on adverse events
Collecting all adverse events during the whole study
Time frame: Up to posttreatment week 24
Percentage of subjects with sustained virologic response 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 4 and 24 weeks after discontinuation of therapy, respectively.
Time frame: Posttreatment Weeks 4 and 24
HCV RNA change from baseline
the quantification of HCV RNA during and after treatment compared with baseline
Time frame: Up to posttreatment week 24
Percentage of subjects with virologic failure
1. On-treatment virologic failure: 1. confirmed HCV RNA ≥ the lower limit of quantitation (LLOQ) after having previously had HCV RNA \<the lower limit of quantitation (LLOQ) while on treatment; 2. confirmed ≥ 1 log10 IU/mL increase in HCV RNA from nadir while on treatment; 3. HCV RNA persistently ≥the lower limit of quantitation (LLOQ) through 8 weeks of treatment. 2. Virologic relapse: 1. 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.
Time frame: Up to posttreatment week 24
Percentage of subjects with viral resistance to DAG181 and/or SOF
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Beijing Ditan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Beijing YouAn Hospital,Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 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
...and 25 more locations
Monitoring HCV virus resistance at baseline, during and after treatment
Time frame: Up to posttreatment week 24