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
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.
- 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