Chronic Hepatitis BPhase 1/2NCT07897448
A Study of Sequential Therapy With AHB-137 Injection Followed by TVAX-008 Injection in Participants Living With Chronic Hepatitis B (CHB)
A Phase 1/2 study testing AHB-137 and TVAX-008 in people with Chronic Hepatitis B, run by Grand Theravac Life Sciences (Hangzhou) Co., Ltd..
Trial summary
This is a study of sequential therapy with AHB-137 injection followed by TVAX-008 injection in participants living with Chronic Hepatitis B (CHB). 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?
- AHB-137 and TVAX-008
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 20 Jun 2029
- Phase
- Phase 1/2
- 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
- Voluntarily participate in the study and sign the informed consent form, and comply with the requirements of the study protocol;
- 18-65 years of age (including boundary values) for men or women;
- Body mass index met the requirements;
- HBeAg negative at screening;
- Meet the relevant requirements for prior medications;
- HBsAg and HBV DNA and liver function indicators meet the requirements;
- Use contraception as required;
Who cannot join
- Uncontrolled and stable clinically significant abnormalities or other serious diseases other than a history of chronic HBV infection;
- Has received treatment with the relevant medication;
- Participants with clinically significant relevant liver diseases, manifestations of liver function decompensation, history of extrahepatic diseases related to HBV immune status, liver fibrosis or cirrhosis, and confirmed or suspected liver cancer;
- Any serious infection other than chronic hepatitis B infection requires intravenous anti-infective therapy;
- HCV RNA positive, HIV antibody positive, syphilis positive within 12 months;
- Abnormal laboratory results;
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- Diseases associated with vascular inflammatory conditions;
- QT interval corrected heart rate (Fridericia method) abnormal;
- History of malignancy or ongoing assessment of possible malignancy;
- History of allergies, or allergic constitution;
- Recent major trauma or major surgery, or planned surgery;
- Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
- Prior/current use of prohibited medications;
- Thyroid function abnormal;
- There are serious cardiovascular and cerebrovascular diseases;
- Inappropriate for participation in this trial as judged by the investigator
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 1/2 Study to Evaluate AHB-137 Injection Followed by TVAX-008 Injection in Participants With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Analogs
This is a study of sequential therapy with AHB-137 injection followed by TVAX-008 injection in participants living with Chronic Hepatitis B (CHB).
- Conditions
- Chronic Hepatitis B
- Being tested
- AHB-137, TVAX-008, Placebo
- Keywords
- Hepatitis B, Chronic
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AHB-137Drug
AHB-137 will be administered per 1 week
TVAX-008Drug
TVAV-008 will be administered per 4 weeks
AHB-137Drug
AHB-137 will be administered per 1 week
PlaceboDrug
Placebo will be used per 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experiment group | Experimental | Not described Receives: Drug: AHB-137; Drug: TVAX-008 |
| Placebo group | Placebo comparator | Not described Receives: Drug: AHB-137; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) in Phase I
Treatment-emergent adverse events (TEAEs) will be assessed during the protocol-defined observation period. The percentage of participants experiencing at least one TEAE will be reported.
Measured: From the first dose of study treatment through the last study visit (up to Week 72)
Percentage of Participants Achieving Clinical Cure (Functional Cure) at 24 Weeks After Discontinuation of All Chronic Hepatitis B Treatments in Phase II
Clinical cure is defined as HBsAg clearance (<0.05 IU/mL) and sustained HBV DNA suppression (<LLOQ), allowing transient viral rebound, at 24 weeks after discontinuation of all CHB treatments, regardless of HBsAb status. The percentage of participants achieving clinical cure will be reported.
Measured: 24 weeks after discontinuation of all chronic hepatitis B treatments (up to Week 72)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start31 Oct 2026 (estimated)
- Primary completion22 Sep 2028 (estimated)
- Study completion20 Jun 2029 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grand Theravac Life Sciences (Hangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ausper Biopharma Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Guiqiang Wang, Principal investigator, Peking University First HospitalYan Wang, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897448
- Sponsor's protocol ID
- AB-SWX-10-8013
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 1/2 Study to Evaluate AHB-137 Injection Followed by TVAX-008 Injection in Participants With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Analogs
- ClinicalTrials.gov ID
- NCT07897448
- Acronym / sponsor ID
- AB-SWX-10-8013
- Conditions
- Chronic Hepatitis B
- Keywords
- Hepatitis B, Chronic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Grand Theravac Life Sciences (Hangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Ausper Biopharma Co., Ltd.
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 22 Sep 2028 (estimated)
- Study completion
- 20 Jun 2029 (estimated)
- First posted
- 27 Oct 2026 (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.
This is a study of sequential therapy with AHB-137 injection followed by TVAX-008 injection in participants living with Chronic Hepatitis B (CHB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment group | Experimental | Drug: AHB-137, Drug: TVAX-008 |
| Placebo group | Placebo comparator | Drug: AHB-137, Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily participate in the study and sign the informed consent form, and comply with the requirements of the study protocol;
- 18-65 years of age (including boundary values) for men or women;
- Body mass index met the requirements;
- HBeAg negative at screening;
- Meet the relevant requirements for prior medications;
Key exclusion criteria (16 listed)
- Uncontrolled and stable clinically significant abnormalities or other serious diseases other than a history of chronic HBV infection;
- Has received treatment with the relevant medication;
- Participants with clinically significant relevant liver diseases, manifestations of liver function decompensation, history of extrahepatic diseases related to HBV immune status, liver fibrosis or cirrhosis, and confirmed or suspected liver cancer;
- Any serious infection other than chronic hepatitis B infection requires intravenous anti-infective therapy;
- HCV RNA positive, HIV antibody positive, syphilis positive within 12 months;
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 |
|---|---|---|
| AHB-137AHB-137 will be administered per 1 week | Drug | Experiment group |
| TVAX-008TVAV-008 will be administered per 4 weeks | Drug | Experiment group |
| AHB-137AHB-137 will be administered per 1 week | Drug | Placebo group |
| PlaceboPlacebo will be used per 4 weeks | Drug | Placebo group |
Primary outcome
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) in Phase I
Time frame: From the first dose of study treatment through the last study visit (up to Week 72)
Treatment-emergent adverse events (TEAEs) will be assessed during the protocol-defined observation period. The percentage of participants experiencing at least one TEAE will be reported.
Percentage of Participants Achieving Clinical Cure (Functional Cure) at 24 Weeks After Discontinuation of All Chronic Hepatitis B Treatments in Phase II
Time frame: 24 weeks after discontinuation of all chronic hepatitis B treatments (up to Week 72)
Clinical cure is defined as HBsAg clearance (<0.05 IU/mL) and sustained HBV DNA suppression (<LLOQ), allowing transient viral rebound, at 24 weeks after discontinuation of all CHB treatments, regardless of HBsAb status. The percentage of participants achieving clinical cure will be reported.
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 27 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Guiqiang Wang principal investigator
Peking University First Hospital
Yan Wang principal investigator
Peking University First Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AHB-137 and TVAX-008 in people with Chronic Hepatitis B, run by Grand Theravac Life Sciences (Hangzhou) Co., Ltd..
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 7 inclusion and 16 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Lina Chen (086+19921306230, chenlina@theravac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) in Phase I (time frame: From the first dose of study treatment through the last study visit (up to Week 72)). The study lists 2 primary outcomes in all. 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 27 Oct 2026.