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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.
Full 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.
Enrollment
Sex
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Volunteers
Inclusion criteria
Willing and able to provide written informed consent;
Male or female, age≥18 years;
A female subject is eligible to enter the study if it is confirmed that she is:
All male subjects must agree to consistently and correctly use specific contraceptive methods with their female partner from screening until 90 days after last dose of study drugs(except for surgical sterilization), such as complete abstinence from intercourse, condom, and their female partner use contraceptives , vaginal ring , cervical cap or contraceptive diaphragm, IUD, etc;
Male subjects must agree to refrain from sperm donation from the date of screening until 90 days after the last dose of study drugs;
Confirmation of chronic HCV infection documented by either:
Serological detection of anti-HCV antibodies was positive at screening;
HCV RNA≥1×104 IU/mL at Screening;
HCV genotype 1a, 1b, or mixed 1a/1b at screening as determined by the Central Laboratory;
Classification as treatment naive or treatment experienced;
Absence of cirrhosis.
Exclusion criteria
Primary purpose
Allocation
Interventional model
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362 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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