Chronic Hepatitis BPhase 2/3NCT07203118
A Phase II/III of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis B
A Phase 2/3 study testing HTS 20mg, HTS 30mg and HTS 40mg in people with Chronic Hepatitis B, run by Xi'an Xintong Pharmaceutical Research Co.,Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- HTS 20mg, HTS 30mg and HTS 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,444 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 28 Feb 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II/III Seamless Design Clinical Trial 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.
- Conditions
- Chronic Hepatitis B
- Being tested
- HTS 20mg, HTS 30mg, HTS 40mg, TAF 25mg
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTS 20mgDrug
Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal.
HTS 30mgDrug
Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal.
HTS 40mgDrug
Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal.
TAF 25mgDrug
Once daily, administered concomitantly with one HTS placebo tablet per dose, taken once daily with or within 30 minutes after a meal.
| Study group | Role | What they receive |
|---|---|---|
| HTS 20mg | Experimental | Not described Receives: Drug: HTS 20mg |
| HTS 30mg | Experimental | Not described Receives: Drug: HTS 30mg |
| HTS 40mg | Experimental | Not described Receives: Drug: HTS 40mg |
| TAF 25mg | Experimental | Not described Receives: Drug: TAF 25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events of the Optimal Dosing Regimen as assessed by CTCAE v5.0
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Jul 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,444 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an Xintong Pharmaceutical Research Co.,Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203118
- Sponsor's protocol ID
- XAXT-2024-001
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Seamless Design Clinical Trial of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT07203118
- Acronym / sponsor ID
- XAXT-2024-001
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,444 participants (estimated)
- Lead sponsor
- Xi'an Xintong Pharmaceutical Research Co.,Ltd.University, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HTS 20mg | Experimental | Drug: HTS 20mg |
| HTS 30mg | Experimental | Drug: HTS 30mg |
| HTS 40mg | Experimental | Drug: HTS 40mg |
| TAF 25mg | Experimental | Drug: TAF 25mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HTS 20mgOnce daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal. | Drug | HTS 20mg |
| HTS 30mgOnce daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal. | Drug | HTS 30mg |
| HTS 40mgOnce daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal. | Drug | HTS 40mg |
| TAF 25mgOnce daily, administered concomitantly with one HTS placebo tablet per dose, taken once daily with or within 30 minutes after a meal. | Drug | TAF 25mg |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing HTS 20mg, HTS 30mg and HTS 40mg in people with Chronic Hepatitis B, run by Xi'an Xintong Pharmaceutical Research Co.,Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.