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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1444 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2030-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No