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

Xi'an Xintong Pharmaceutical Research

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Chronic Hepatitis B

Treatments: Drug: HTS 30mg; Drug: HTS 40mg; Drug: HTS 20mg; Drug: TAF 25mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07203118

XAXT-2024-001

Details and patient eligibility

About

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.

Enrollment: 1,444 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,444 participants in 4 patient groups

HTS 20mg

Experimental group

Treatment:

Drug: HTS 20mg

HTS 30mg

Experimental group

Treatment:

Drug: HTS 30mg

HTS 40mg

Experimental group

Treatment:

Drug: HTS 40mg

TAF 25mg

Experimental group

Treatment:

Drug: TAF 25mg