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A Phase II/III of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis B
Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd.
Summary
UsingTAF as the control, the nvestigators aim to further explore the efficacy and safety of different dosages of HTS in the treatment of patients with chronic hepatitis B; ultimately, the nvestigators determine the optimal recommended dosage of HTS to provide a basis for Phase III confirmatory clinical research.
Official title: A Phase II/III Seamless Design Clinical Trial of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis B
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
1444
Start Date
2025-07-01
Completion Date
2030-02-28
Last Updated
2025-10-02
Healthy Volunteers
No
Conditions
Interventions
HTS 20mg
Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal.
HTS 30mg
Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal.
HTS 40mg
Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal.
TAF 25mg
Once daily, administered concomitantly with one HTS placebo tablet per dose, taken once daily with or within 30 minutes after a meal.
Locations (1)
The First Hospital of Jilin University
Jilin, changchun, China