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

Not Applicable

Active, not recruiting

• Conditions: Chronic Hepatitis B
• Interventions: Drug: HTS 20mg; Drug: HTS 30mg; Drug: HTS 40mg; Drug: TAF 25mg

• Registration Number: NCT07203118
• Lead Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-07-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-15
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Primary Completion: 2027-06-30
• Study Completion: 2030-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1444

Inclusion Criteria

1）Age between 18 to 65 years old (inclusive), regardless of gender. 2) Meets diagnostic criteria for chronic hepatitis B (documented HBsAg positivity or HBV DNA positivity for more than 6 months, or confirmed by liver biopsy histopathology).

3)No prior treatment with any nucleos(t)ide analogue oral antiviral therapy; or, previous treatment with any nucleos(t)ide analogue must have ended at least 6 months prior to baseline.

4) Any interferon therapy (both pegylated and non-pegylated) must be completed at least 1 year prior to baseline visit.

5) Willing to use effective non-pharmacological contraception during the trial period.

Exclusion Criteria

1. Hypersensitive to the study drug, its metabolites or any excipient in its formula;
2. With previous or present clinical hepatic decompensation (e.g., ascites, hepatic encephalopathy or varicose vein haemorrhage)
3. Complicated with liver diseases, including chronic alcoholic hepatitis, drug-induced hepatitis, etc.
4. Complicated with HCV, HIV or HDV infections
5. Documented resistance to the antiviral drug (Tenofovir).
6. Any cardiovascular, hematologic,pulmonary or nervous diseases deemed serious by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HTS 20mg	HTS 20mg	-
HTS 30mg	HTS 30mg	-
HTS 40mg	HTS 40mg	-
TAF 25mg	TAF 25mg	-

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events of the Optimal Dosing Regimen as assessed by CTCAE v5.0	through study completion, an average of 1 year

Trial Locations

Locations (1)

The First Hospital of Jilin University; 🇨🇳 Jilin, changchun, China