Chronic Hepatitis BPhase 2NCT07137910
A Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)
A Phase 2 study testing AHB-137 and NA therapy in people with Chronic Hepatitis B, run by Ausper Biopharma Co., Ltd. at 12 sites in China.
Trial summary
This is an open-label, multicenter, Phase 2 study designed to evaluate the efficacy and safety of AHB-137 injection in participants with chronic hepatitis B (CHB) with low hepatitis B surface antigen (HBsAg) levels. 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 NA therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 12 sitesChina
- Study dates
- 4 Sep 2025to 1 Jun 2027
- Phase
- Phase 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;
- 18-65 years of age (including boundary values) ;
- Body mass index met the requirements;
- Participants with CHB who are HBsAg or HBV DNA positive for at least 6 months;
- Meet the relevant requirements for prior medications;
- HBsAg and HBV DNA and liver function indicators meet the requirements;
- Effective contraception as required;
Who cannot join
- Uncontrolled and stable clinically significant abnormalities other than a history of CHB infection;
- Associated liver disease;
- Any serious infection other than CHB infection requires intravenous anti-infective therapy;
- HCV RNA positive, HIV antibody positive, syphilis positive;
- Abnormal laboratory results;
- Diseases associated with vascular inflammatory conditions;
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- QT interval corrected heart rate (Fridericia method) abnormal;
- History of malignancy or ongoing assessment of possible malignancy;
- History of allergies, or allergic constitution;
- Participants with recent major trauma or major surgery, or planning 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;
- Inappropriate for participation in this trial as judged by the investigator.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
AusperBio Investigational Site
Beijing, Beijing Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
- Not yet recruiting
AusperBio Investigational Site
Changzhou, Jiangsu
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
- Not yet recruiting
AusperBio Investigational Site
Chengdu, Sichuan
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
- Not yet recruiting
AusperBio Investigational Site
Chongqing, Chongqing Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
- Not yet recruiting
AusperBio Investigational Site
Chongqing, Chongqing Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
- Not yet recruiting
AusperBio Investigational Site
Guangzhou, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
- Not yet recruiting
AusperBio Investigational Site
Hangzhou, Zhejiang
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
- Recruiting
AusperBio Investigational Site
Jilin City, Changchun
Lu, 0571-86959519, clinicaltrial@ausperbio.com
- Recruiting
AusperBio Investigational Site
Nanning, Guangxi
Lu, 057186959519, clinicaltrial@ausperbio.com
- Not yet recruiting
AusperBio Investigational Site
Shenzhen, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
- Recruiting
AusperBio Investigational Site
Xiamen, Fujian
Lu, 057186959519, clinicaltrial@ausperbio.com
- Not yet recruiting
AusperBio Investigational Site
Zhengzhou, Henan
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
About this study
Official title: An Open-Label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Low-HBsAg Chronic Hepatitis B
This is an open-label, multicenter, Phase 2 study designed to evaluate the efficacy and safety of AHB-137 injection in participants with chronic hepatitis B (CHB) with low hepatitis B surface antigen (HBsAg) levels.
- Conditions
- Chronic Hepatitis B
- Being tested
- AHB-137, NA therapy
- Keywords
- Hepatitis B, Chronic
- 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.
AHB-137Drug
AHB-137 will be injected
NA therapyDrug
NA will be usede.
| Study group | Role | What they receive |
|---|---|---|
| Part A: AHB-137 With NA Therapy | Experimental | Not described Receives: Drug: AHB-137; Drug: NA therapy |
| Part B: AHB-137 with NA Therapy | Experimental | Not described Receives: Drug: AHB-137; Drug: NA therapy |
| Part B: AHB-137 Without NA Therapy | Experimental | Not described Receives: Drug: AHB-137 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ) at the 24th week after all treatment for CHB was discontinued.
Measured: At the 24th week after all treatment for CHB was discontinued
Secondary outcomes (10)
Proportion of participants with persistent HBV DNA < LLOQ .
Measured: During the 24-week period after discontinuation of all CHB treatment
Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ).
Measured: Up to 60 weeks
Detection of the concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg.
Measured: Up to 60 weeks
Relapse rate and time after discontinuation of NAs therapy.
Measured: Up to 60 weeks
Changes of the score of Health-Related Quality of Life (HBQOL) in participants compared with baseline.
Measured: Up to 60 weeks
Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline.
Measured: Up to 60 weeks
Number and percentage of participants with detectable anti-drug antibodies (ADA).
Measured: Up to 60 weeks
Sequencing of the Viral DNA and/or viral RNA analysis for detection of drug resistance in the target region of AHB-137.
Measured: Up to 60 weeks
Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.
Examination including laboratory examination, electrocardiogram (ECG) examination.
Measured: Up to 60 weeks
Plasma concentrations of AHB-137.
Measured: Up to 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start4 Sep 2025
- Primary completion12 Dec 2026 (estimated)
- Study completion1 Jun 2027 (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.
- More trials run by Ausper Biopharma Co., Ltd.The sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ausper Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junqi Niu, Principal investigator, The First Hospital of Jilin UniversityYanhua Ding, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137910
- Sponsor's protocol ID
- AB-10-8009
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2025
- Last updated
- 5 Aug 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 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Low-HBsAg Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT07137910
- Acronym / sponsor ID
- AB-10-8009
- Conditions
- Chronic Hepatitis B
- Keywords
- Hepatitis B, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ausper Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 22 Aug 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.
This is an open-label, multicenter, Phase 2 study designed to evaluate the efficacy and safety of AHB-137 injection in participants with chronic hepatitis B (CHB) with low hepatitis B surface antigen (HBsAg) levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: AHB-137 With NA Therapy | Experimental | Drug: AHB-137, Drug: NA therapy |
| Part B: AHB-137 with NA Therapy | Experimental | Drug: AHB-137, Drug: NA therapy |
| Part B: AHB-137 Without NA Therapy | Experimental | Drug: AHB-137 |
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;
- 18-65 years of age (including boundary values) ;
- Body mass index met the requirements;
- Participants with CHB who are HBsAg or HBV DNA positive for at least 6 months;
- Meet the relevant requirements for prior medications;
Key exclusion criteria (13 listed)
- Uncontrolled and stable clinically significant abnormalities other than a history of CHB infection;
- Associated liver disease;
- Any serious infection other than CHB infection requires intravenous anti-infective therapy;
- HCV RNA positive, HIV antibody positive, syphilis positive;
- Abnormal laboratory results;
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 injected | Drug | Part A: AHB-137 With NA Therapy, Part B: AHB-137 Without NA Therapy, Part B: AHB-137 with NA Therapy |
| NA therapyNA will be usede. | Drug | Part A: AHB-137 With NA Therapy, Part B: AHB-137 with NA Therapy |
Primary outcome
Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ) at the 24th week after all treatment for CHB was discontinued.
Time frame: At the 24th week after all treatment for CHB was discontinued
10 secondary outcomes
Proportion of participants with persistent HBV DNA < LLOQ .
Time frame: During the 24-week period after discontinuation of all CHB treatment
Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ).
Time frame: Up to 60 weeks
Detection of the concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg.
Time frame: Up to 60 weeks
Relapse rate and time after discontinuation of NAs therapy.
Time frame: Up to 60 weeks
Changes of the score of Health-Related Quality of Life (HBQOL) in participants compared with baseline.
Time frame: Up to 60 weeks
Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline.
Time frame: Up to 60 weeks
Number and percentage of participants with detectable anti-drug antibodies (ADA).
Time frame: Up to 60 weeks
Sequencing of the Viral DNA and/or viral RNA analysis for detection of drug resistance in the target region of AHB-137.
Time frame: Up to 60 weeks
Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.
Time frame: Up to 60 weeks
Plasma concentrations of AHB-137.
Time frame: Up to 60 weeks
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 5 Aug 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.
Junqi Niu principal investigator
The First Hospital of Jilin University
Yanhua Ding principal investigator
The First Hospital of Jilin University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AHB-137 and NA therapy in people with Chronic Hepatitis B, run by Ausper Biopharma Co., Ltd. at 12 sites 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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 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.
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 Lu (0571-86959519, clinicaltrial@ausperbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ) at the 24th week after all treatment for CHB was discontinued. (time frame: At the 24th week after all treatment for CHB was discontinued). 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 5 Aug 2026.