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

May 1, 2026 updated by: Ausper Biopharma Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
577

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Placebo will be injected weekly by subcutaneous injection.Two additional doses given on day 4 and day 11.
Drug: NA therapy
NA will be the background therapy. After stopping the AHB-137 or placebo injection, continue for another 12 weeks.
Experimental: AHB-137
Drug: AHB-137
AHB-137 will be injected weekly by subcutaneous injection. There are 2 leading doses on day 4 and day 11.
Drug: NA therapy
NA will be the background therapy. After stopping the AHB-137 or placebo injection, continue for another 12 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
24 weeks after discontinuation of all CHB treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma concentrations of AHB-137.
Time Frame: Up to 60 weeks
Up to 60 weeks
Proportion of participants with persistent HBV DNA < LLOQ .
Time Frame: 24 weeks after discontinuation of all CHB treatment
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
Up to 60 weeks
Concentration of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb,HBeAg, HBeAb
Time Frame: Up to 60 weeks
Up to 60 weeks
Relapse rate after discontinuation of NAs therapy.
Time Frame: Up to 60 weeks
Up to 60 weeks
Safety: Number and percentage of participants with detectable anti-drug antibodies (ADA).
Time Frame: Up to 60 weeks
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
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
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
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.
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
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.
Up to 60 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ausper Biopharma Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: AusperBio Clinical Trials, AusperBio Investigational Site

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 18, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AB-10-8006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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