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ACTIVE NOT RECRUITING
NCT07203118
PHASE2/PHASE3

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

Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd.

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

The First Hospital of Jilin University

Jilin, changchun, China