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

NCT07203118 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1444

Last updated 2025-10-02

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Xi'an Xintong Pharmaceutical Research Co.,Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2027-06-30
Completion
2030-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07203118 on ClinicalTrials.gov