NCT07203118

A Phase II/III of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis B

A Phase II/III Seamless Design Clinical Trial of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis B

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,444 (estimated)
• Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	HTS 20mg	Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal.
DRUG	HTS 30mg	Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal.
DRUG	HTS 40mg	Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal.
DRUG	TAF 25mg	Once daily, administered concomitantly with one HTS placebo tablet per dose, taken once daily with or within 30 minutes after a meal.

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-06-30
• Completion: 2030-02-28
• First posted: 2025-10-02
• Last updated: 2025-10-02

Locations

1 site across 1 country: China