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NCT Number: NCT07203118

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The First Hospital of Jilin University

Jilin City, changchun, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

  • Any interferon therapy (both pegylated and non-pegylated) must be completed at least 1 year prior to baseline visit.
  • Willing to use effective non-pharmacological contraception during the trial period.

Exclusion criteria

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

Treatment and study plan

HTS 20mg

Drug

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

HTS 30mg

Drug

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

HTS 40mg

Drug

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

TAF 25mg

Drug

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

Primary outcomes

  1. Number of participants with treatment-related adverse events of the Optimal Dosing Regimen as assessed by CTCAE v5.0

    Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Xi'an Xintong Pharmaceutical Research Co.,Ltd.

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Oct 2, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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