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

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: Active, not recruiting
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: AHB-137; Drug: Placebo; Drug: NA therapy

• Study Type: Interventional
• Enrollment (Actual): 577
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	24 weeks after discontinuation of all CHB treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentrations of AHB-137.		Up to 60 weeks
Proportion of participants with persistent HBV DNA < LLOQ .		24 weeks after discontinuation of all CHB treatment
Proportion of participants with persistent HBsAg < LOD and HBV DNA < LLOQ		Up to 60 weeks
Concentration of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb,HBeAg, HBeAb		Up to 60 weeks
Relapse rate after discontinuation of NAs therapy.		Up to 60 weeks
Safety: Number and percentage of participants with detectable anti-drug antibodies (ADA).		Up to 60 weeks
Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.		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		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.	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.	Up to 60 weeks

Collaborators and Investigators

• Sponsor: Ausper Biopharma Co., Ltd.
• Investigators: Study Director: AusperBio Clinical Trials, AusperBio Investigational Site

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2025
• Primary Completion (Estimated): December 18, 2026
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: August 12, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Hepatitis B, Chronic
• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis, Chronic; Hepatitis; Pathological Conditions, Signs and Symptoms; Hepatitis B; Hepatitis B, Chronic
• Other Study ID 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