Chronic Hepatitis BPhase 3NCT07246889

Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE)

A Phase 3 study testing AHB-137 and NA therapy in people with Chronic Hepatitis B, run by Ausper Biopharma Co., Ltd. at 28 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This study is a randomized, double-blind, multicenter phase 3 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with NAs. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Hepatitis B
What is being tested?: AHB-137 and NA therapy
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 577 participants
Where: 28 sitesChina
Study dates: 12 Aug 2025to 31 Oct 2027
Phase: Phase 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study according to the protocol;
At least 18 years of age at the time of signing the ICF;
Body mass index met the requirements;
HBeAg negative at screening;
HBsAg or HBV DNA positive for at least 6 months;
Meet relevant requirements for NAs treatment;
100 IU/mL < HBsAg ≤ 3000 IU/mL, HBV DNA < 100 IU/mL and liver function indicators meet the requirements;
Effective contraception as required.

Who cannot join

Clinically significant abnormalities other than a history of chronic HBV infection;
Concomitant clinically significant other liver diseases;
Previous/current manifestations of hepatic decompensation;
Significant hepatic fibrosis or cirrhosis;
Presence of protocol-specified laboratory abnormalities;
History of malignancy or ongoing assessment of possible malignancy;

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Those allergic to AHB-137 or its components;
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

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

China28 sites

AusperBio Investigational Site
Beijing, Beijing Municipality
AusperBio Investigational Site
Changchun, Jilin
AusperBio Investigational Site
Changsha, Hunan
AusperBio Investigational Site
Chengdu, Sichuan
AusperBio Investigational Site
Chongqing, Chongqing Municipality
AusperBio Investigational Site
Foshan, Guangdong
AusperBio Investigational Site
Fuzhou, Fujian
AusperBio Investigational Site
Guangzhou, Guangdong
AusperBio Investigational Site
Guiyang, Guizhou
AusperBio Investigational Site
Haikou, Hainan
AusperBio Investigational Site
Hangzhou, Zhejiang
AusperBio Investigational Site
Hefei, Anhui
AusperBio Investigational Site
Kunming, Yunnan
AusperBio Investigational Site
Lanzhou, Gansu
AusperBio Investigational Site
Liuzhou, Guangxi
AusperBio Investigational Site
Nanchang, Jiangxi
AusperBio Investigational Site
Nanjing, Jiangsu
AusperBio Investigational Site
Nanning, Guangxi
AusperBio Investigational Site
Shanghai, Shanghai Municipality
AusperBio Investigational Site
Shenyang, Liaoning
AusperBio Investigational Site
Shenzhen, Guangdong
AusperBio Investigational Site
Taiyuan, Shanxi
AusperBio Investigational Site
Wuhan, Hubei
AusperBio Investigational Site
Xi’an, Shanxi
AusperBio Investigational Site
Xiamen, Fujian
AusperBio Investigational Site
Zhengzhou, Henan
AusperBio Investigational Site
Zhenjiang, Jiangsu
AusperBio Investigational Site
Zunyi, Guizhou

Other trials in China

About this study

Official title: A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With HBeAg-negative Chronic Hepatitis B Treated With Nucleos(t)Ide Analogues

This study is a randomized, double-blind, multicenter phase 3 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with NAs.

Conditions: Chronic Hepatitis B
Being tested: AHB-137, Placebo, 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 weekly by subcutaneous injection. There are 2 leading doses on day 4 and day 11.
PlaceboDrug
Placebo will be injected weekly by subcutaneous injection.Two additional doses given on day 4 and day 11.
NA therapyDrug
NA will be the background therapy. After stopping the AHB-137 or placebo injection, continue for another 12 weeks.

Study groups in NCT07246889
Study group	Role	What they receive
AHB-137	Experimental	Not described Receives: Drug: AHB-137; Drug: NA therapy
Placebo	Placebo comparator	Not described Receives: Drug: Placebo; Drug: NA therapy

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: 24 weeks after discontinuation of all CHB treatment

Secondary outcomes (10)

Proportion of participants with persistent HBV DNA < LLOQ .
Measured: 24 weeks after discontinuation of all CHB treatment
Proportion of participants with persistent HBsAg < LOD and HBV DNA < LLOQ
Measured: Up to 60 weeks
Concentration of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb,HBeAg, HBeAb
Measured: Up to 60 weeks
Relapse rate after discontinuation of NAs therapy.
Measured: Up to 60 weeks
Safety: Number and percentage of participants with detectable anti-drug antibodies (ADA).
Measured: Up to 60 weeks
Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.
Measured: Up to 60 weeks
Plasma concentrations of AHB-137.
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
Change from baseline in EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) scores in participants with HBV infection.
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 patient's health state.
Measured: Up to 60 weeks
Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline.
This scale has 31 items, including 7 dimensions: psychological status, expected anxiety, vitality, shame, infectivity, health vulnerability, and viral response. Each item is scored on a 5-point scale, with higher scores indicating a more severe impact of hepatitis B on quality of life.
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.

12 Aug 202531 Oct 2027

First posted24 Nov 2025
Study start12 Aug 2025
Primary completion18 Dec 2026 (estimated)
Study completion31 Oct 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 577 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07246889
Sponsor's protocol ID: AB-10-8006
Status last verified: May 2026
First submitted: 12 Aug 2025
Last updated: 4 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

All Chronic Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With HBeAg-negative Chronic Hepatitis B Treated With Nucleos(t)Ide Analogues
ClinicalTrials.gov ID: NCT07246889
Acronym / sponsor ID: AB-10-8006
Conditions: Chronic Hepatitis B
Keywords: Hepatitis B, Chronic
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 577 participants (actual)
Lead sponsor: Ausper Biopharma Co., Ltd.Industry (pharma, biotech, devices)
Study start: 12 Aug 2025 (actual)
Primary completion: 18 Dec 2026 (estimated)
Study completion: 31 Oct 2027 (estimated)
First posted: 24 Nov 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 study is a randomized, double-blind, multicenter phase 3 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with NAs.

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
AHB-137	Experimental	Drug: AHB-137, Drug: NA therapy
Placebo	Placebo comparator	Drug: Placebo, Drug: NA therapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study according to the protocol;
At least 18 years of age at the time of signing the ICF;
Body mass index met the requirements;
HBeAg negative at screening;
HBsAg or HBV DNA positive for at least 6 months;

Key exclusion criteria (11 listed)

Clinically significant abnormalities other than a history of chronic HBV infection;
Concomitant clinically significant other liver diseases;
Previous/current manifestations of hepatic decompensation;
Significant hepatic fibrosis or cirrhosis;
Presence of protocol-specified laboratory abnormalities;

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 weekly by subcutaneous injection. There are 2 leading doses on day 4 and day 11.	Drug	AHB-137
PlaceboPlacebo will be injected weekly by subcutaneous injection.Two additional doses given on day 4 and day 11.	Drug	Placebo
NA therapyNA will be the background therapy. After stopping the AHB-137 or placebo injection, continue for another 12 weeks.	Drug	AHB-137, Placebo

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: 24 weeks after discontinuation of all CHB treatment

10 secondary outcomes

Proportion of participants with persistent HBV DNA < LLOQ .
Time frame: 24 weeks after discontinuation of all CHB treatment
Proportion of participants with persistent HBsAg < LOD and HBV DNA < LLOQ
Time frame: Up to 60 weeks
Concentration of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb,HBeAg, HBeAb
Time frame: Up to 60 weeks
Relapse rate after discontinuation of NAs therapy.
Time frame: Up to 60 weeks
Safety: Number and percentage of participants with detectable anti-drug antibodies (ADA).
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
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
Change from baseline in EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) scores in participants with HBV infection.
Time frame: Up to 60 weeks
Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline.
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 4 May 2026.
Individual participant dataSharing planned: No

Related trials for Chronic Hepatitis B

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
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.

AusperBio Clinical Trials study director

AusperBio Investigational Site

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AHB-137 and NA therapy in people with Chronic Hepatitis B, run by Ausper Biopharma Co., Ltd. at 28 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 8 inclusion and 11 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 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 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. 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 phase mean?

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?

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: 24 weeks after discontinuation of all CHB treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07246889.

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 4 May 2026.