Chronic Hepatitis BPhase 2NCT07635186
A Study to Evaluate AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B
A Phase 2 study testing AHB-137 in people with Chronic Hepatitis B, run by Ausper Biopharma Co., Ltd. at 34 sites in China.
Trial summary
This study is a randomized, double-blind, placebo-controlled, multicenter phase 2 study to assess the efficacy and safety of AHB-137 injection in treatment-naïve participants with chronic hepatitis B. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 34 sitesChina
- Study dates
- 5 Jun 2026to 20 Jun 2028
- 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
- Volunteer to participate and sign the informed consent form, and are willing to complete the study in accordance with the requirements of the protocol.
- Aged 18-65 years (including boundary values).
- Body mass index between the range of 18-32 kg/m2 (inclusive boundary values).
- HBsAg or HBV DNA positive for ≥ 6 months at screening and no antiviral treatment with interferon or nucleoside analogue.
- HBsAg and HBV DNA values met protocol requirements at screening.
- ALT < 3xULN at screening.
- Use highly effective contraception as required.
Who cannot join
- Uncontrolled and stable clinically significant abnormalities other than a history of chronic HBV infection.
- Participants with other clinically significant liver diseases, previous/current manifestations of hepatic decompensation, and a history of extrahepatic diseases that may be related to HBV immune status.
- Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to randomization.
- Hepatitis C virus (HCV) infection or < 12 months from cure at screening (HCV RNA positive within 12 months), human immunodeficiency virus (HIV) positive at screening, and syphilis positive (treponema pallidum antibody positive).
- Significant fibrosis or cirrhosis, or liver stiffness value (LSM) > 9.0 kPa at screening.
- Participants with confirmed or suspected liver cancer who have a history of malignancy within the past 5 years or are undergoing assessment for a possible malignancy.
Show all 17Show fewer
- Laboratory test results do not meet the criteria.
- Prior/current autoimmune disease, history of vasculitis, or presence of signs, symptoms, or laboratory tests of underlying vasculitis.
- Fridericia ' s formula corrected QT interval (QTcF) ≥ 450 msec for male participants and ≥ 470 msec for female participants at screening.
- Allergic to AHB-137 ingredients, or history of drug allergy or other allergies.
- Major trauma or major surgery within 3 months prior to screening, or planned surgery during the trial.
- Participants are participating in another clinical trial or failing to wash out as required.
- Current use or use of any immunosuppressive medication (e.g. prednisone) within 3 months prior to screening, except for short courses (≤ 2 weeks) or use of topical/inhaled steroids;Those who have used immunomodulators within 3 months prior to screening;Those who have used cytotoxic drugs within 6 months prior to screening;History of vaccination within 1 month prior to screening or a live vaccination plan during the trial.
- Participants that require regular long-term anticoagulants.
- Abnormal thyroid function.
- Participants that have received any antisense oligonucleic acid, siRNA, capsid assembly modulator (CAM) antiviral drug used to treat chronic hepatitis B.
- Any other circumstances or conditions in which, in the opinion of the investigator, the participant is inappropriate for participation in this trial.
Trial locations and contacts
34 sites in 1 country. Contact the study team or a site near you to ask about taking part.
34 sites in 1 country
China34 sites, 34 recruiting
- Recruiting
AusperBio Investigational Site
Beijing, Beijing Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
Yao Xie
- Recruiting
AusperBio Investigational Site
Changchun, Jilin
Lu, 057186959519, clinicaltrial@ausperbio.com
Yanhang Gao
- Recruiting
AusperBio Investigational Site
Changsha, Hunan
Lu, 057186959519, clinicaltrial@ausperbio.com
Yan Huang
- Recruiting
AusperBio Investigational Site
Changsha, Hunan
Lu, 057186959519, clinicaltrial@ausperbio.com
Yongfang Jiang
- Recruiting
AusperBio Investigational Site
Changsha, Hunan
Lu, 057186959519, clinicaltrial@ausperbio.com
Jing Ma
- Recruiting
AusperBio Investigational Site
Chengdu, Sichuan
Lu, 057186959519, clinicaltrial@ausperbio.com
Hong Tang
- Recruiting
AusperBio Investigational Site
Chengdu, Sichuan
Lu, 057186959519, clinicaltrial@ausperbio.com
Jianmei Lin
- Recruiting
AusperBio Investigational Site
Chengdu, Sichuan
Lu, 057186959519, clinicaltrial@ausperbio.com
Li Zhu
- Recruiting
AusperBio Investigational Site
Chongqing, Chongqing Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
Guicheng Wu
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
Peng Hu
- Recruiting
AusperBio Investigational Site
Guangzhou, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
Bingliang Lin
- Recruiting
AusperBio Investigational Site
Guangzhou, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
Yujuan Guan
- Recruiting
AusperBio Investigational Site
Guangzhou, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
Xingfei Pan
- Recruiting
AusperBio Investigational Site
Hangzhou, Zhejiang
Lu, 057186959519, clinicaltrial@ausperbio.com
Guoping Sheng
- Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Lu, 057186959519, clinicaltrial@ausperbio.com
Yunqing Qiu
- Recruiting
AusperBio Investigational Site
Jiangmen, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
Gang He
- Recruiting
AusperBio Investigational Site
Kunming, Yunan
Lu, 057186959519, clinicaltrial@ausperbio.com
Hui Li
- Recruiting
AusperBio Investigational Site
Liuzhou, Guangxi
Lu, 057186959519, clinicaltrial@ausperbio.com
Jiaguang Hu
- Recruiting
AusperBio Investigational Site
Meizhou, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
Tianhuang Liu
- Recruiting
AusperBio Investigational Site
Nanchang, Jiangxi
Lu, 057186959519, clinicaltrial@ausperbio.com
Xiaoping Wu
- Recruiting
AusperBio Investigational Site
Nanjing, Jiangsu
Lu, 057186959519, clinicaltrial@ausperbio.com
Jie Li
- Recruiting
AusperBio Investigational Site
Qingyuan, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
Xi He
- Recruiting
AusperBio Investigational Site
Shanghai, Shanghai Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
Qing Xie
- Recruiting
AusperBio Investigational Site
Shanghai, Shanghai Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
Jiming Zhang
- Recruiting
AusperBio Investigational Site
Shanghai, Shanghai Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
Liang Chen
- Recruiting
AusperBio Investigational Site
Shenyang, Liaoning
Lu, 057186959519, clinicaltrial@ausperbio.com
Yang Ding
- Recruiting
AusperBio Investigational Site
Shenzhen, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
Hongzhou Lu
- Recruiting
AusperBio Investigational Site
Shenzhen, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
Guoxin Hu
- Recruiting
AusperBio Investigational Site
Wuhan, Hubei
Lu, 057186959519, clinicaltrial@ausperbio.com
Xin Zheng
- Recruiting
AusperBio Investigational Site
Wuhan, Hubei
Lu, 057186959519, clinicaltrial@ausperbio.com
Kai Dai
- Recruiting
AusperBio Investigational Site
Xi’an, Shanxi
Lu, 057186959519, clinicaltrial@ausperbio.com
Yingli He
- Recruiting
AusperBio Investigational Site
Xi’an, Shanxi
Lu, 057186959519, clinicaltrial@ausperbio.com
Shuangsuo Dang
- Recruiting
AusperBio Investigational Site
Xiamen, Fujian
Lu, 057186959519, clinicaltrial@ausperbio.com
Qianguo Mao
- Recruiting
AusperBio Investigational Site
Yichang, Hubei
Lu, 057186959519, clinicaltrial@ausperbio.com
Xiaolin Zhou
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Clinical Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B.
This study is a randomized, double-blind, placebo-controlled, multicenter phase 2 study to assess the efficacy and safety of AHB-137 injection in treatment-naïve participants with chronic hepatitis B.
- Conditions
- Chronic Hepatitis B
- Being tested
- AHB-137, Placebo
- Keywords
- Chronic Hepatitis B
- 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 administered subcutaneously.
PlaceboDrug
Placebo will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| AHB-137 | Experimental | AHB-137 will be administered subcutaneously. Receives: Drug: AHB-137 |
| Placebo | Placebo comparator | Placebo will be administered subcutaneously. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV DNA < lower limit of quantitation (LLOQ), 10 IU/mL, HBsAg < limit of detection (LOD), 0.05 IU/mL with or without hepatitis B virus surface antibody (HBsAb) 24 weeks after discontinuation of all chronic hepatitis B treatment.
Measured: Up to 48 weeks.
Highly sensitive HBsAg < 0.005 IU/mL and HBV DNA < LLOQ (10 IU/mL) at the end of treatment.
Measured: Up to 48 weeks.
Secondary outcomes (20)
HBV DNA < LLOQ, 10 IU/mL, and HBsAg < 10 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment.
Measured: Up to 48 weeks.
HBV DNA < LLOQ 24 weeks after discontinuation of all chronic hepatitis B treatment.
Measured: Up to 48 weeks.
HBV DNA < LLOQ and HBsAg < 100 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment.
Measured: Up to 48 weeks.
HBsAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment.
HBsAg seroconversion : serum HBsAg<LOD, and at the same time or subsequently, HBsAb>10 IU/L.
Measured: Up to 48 weeks.
HBeAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment.
HBeAg seroconversion:HBeAg negative, with simultaneous or subsequent positivity for HBeAb.
Measured: Up to 48 weeks.
Proportion of participants who discontinued all chronic hepatitis B treatment at the end of treatment.
Measured: Up to 48 weeks.
HBV DNA < LLOQ and HBsAg < LOD rate and HBV DNA < LLOQ and HBsAg < 10 IU/mL rate by visit.
Measured: Up to 48 weeks.
HBsAg, HBeAg seroconversion rates by visit.
HBsAg seroconversion: serum HBsAg<LOD, and at the same time or subsequently, HBsAb>10 IU/L.
HBeAg seroconversion: HBeAg negative, with simultaneous or subsequent positivity for HBeAb.
Measured: Up to 48 weeks.
Test Values of Virological Parameters.
HBsAb, HBsAg, HBV DNA values and changes from baseline at each visit.
Measured: Up to 48 weeks.
Time to first achievement of HBsAg and first HBeAg seroconversion.
HBsAg seroconversion: serum HBsAg<LOD, and at the same time or subsequently, HBsAb>10 IU/L.
HBeAg seroconversion: HBeAg negative, with simultaneous or subsequent positivity for HBeAb.
Measured: Up to 48 weeks.
Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline.
Response options range from 1 to 5 with higher scores indicating more severe impact .
Measured: Up to 48 weeks.
Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline.
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the participant's health state.
Measured: Up to 48 weeks.
Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA.
Measured: Up to 48 weeks.
Change from baseline in alanine aminotransferase (ALT) and noninvasive assessment of liver fibrosis at each visit.
Measured: Up to 48 weeks.
Time to normalization of ALT without rescue therapy (for participants with abnormal baseline ALT).
Measured: Up to 48 weeks.
AHB-137 resistance analysis.
Method: Sequencing of HBV DNA/RNA.
Measured: Up to 48 weeks.
Proportion of participants who are HBeAb positive and HBeAg negative, and the test values of HBsAb, HBsAg and HBV DNA meet certain conditions.
Measured: Up to 48 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 48 weeks.
Proportion of participants with positive anti-drug antibody (ADA) and ADA level at each visit.
Measured: Up to 48 weeks.
Plasma drug concentration of AHB-137.
Measured: Up to 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start5 Jun 2026
- Primary completion20 Jun 2027 (estimated)
- Study completion20 Jun 2028 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ausper Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yunqing Qiu, Principal investigator, First Affiliated Hospital of Zhejiang UniversityPeng Hu, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635186
- Sponsor's protocol ID
- AB-10-8016
- Status last verified
- Jul 2026
- First submitted
- 28 May 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No