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Clinical Trials in China / NCT07203118
Active, not recruiting Phase 2/3

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

NCT07203118 · tracked via the Priya Life Science China tracker
Sponsor
Xi'an Xintong Pharmaceutical Research Co.,Ltd
Phase
Phase 2/3
Started
2025-07-01
Last updated
2025-10-02

Condition(s) studied

Chronic Hepatitis B

Investigational drug(s) / intervention(s)

HTS 20mgHTS 30mgHTS 40mgTAF 25mg

HTS 20mg: Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal.

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

HTS 40mg: Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal.

TAF 25mg: Once daily, administered concomitantly with one HTS placebo tablet per dose, taken once daily with or within 30 minutes after a meal.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
The First Hospital of Jilin University Jilin City changchun

More Xi'an Xintong Pharmaceutical Research Co.,Ltd. trials in China

A Randomized, Double-blind, Single-center Phase I/IIa Study of XTYW007 Tablets in Subjects. Starting soon
Efficacy and Safety of Pracytarabine Versus Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma Active, not recruiting

Other trials for the same condition

A Phase II Clinical Study of BW-20507 in Combination With PEG-IFNα for the Treatment of Hepatitis B Active, not recruiting
Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients With Chronic HBV Infection Active, not recruiting
Clinical Outcomes of HBeAg-negative CHB Patients With Indeterminate Phase Recruiting
Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With Chronic Hepatitis B (CHB) Active, not recruiting
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B. Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07203118 on ClinicalTrials.gov ↗ ← All trials in China