NCT07203118Active, not recruitingPhase 2/3
A Phase II/III of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis B
A Phase II/III Seamless Design Clinical Trial of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis B
Source: ClinicalTrials.gov · Last updated 2 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 1444 (estimated)
- First submitted
- 15 Sept 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Xi'an Xintong Pharmaceutical Research Co.,Ltd.
- Diseases
- Hepatitis B
- NCT number
- NCT07203118
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 1444
- From 1 Jul 2025 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Documented resistance to the antiviral drug (Tenofovir).
Other illness
- Complicated with liver diseases, including chronic alcoholic hepatitis, drug-induced hepatitis, etc.
- Complicated with HCV, HIV or HDV infections
- Any cardiovascular, hematologic,pulmonary or nervous diseases deemed serious by the investigator
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Jilin City | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.