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

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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

NCT07246889•Ausper Biopharma Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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;
+1 more criteria

Locations (28)

AusperBio Investigational Site

Hefei, Anhui, China

AusperBio Investigational Site

Beijing, Beijing Municipality, China

AusperBio Investigational Site

Chongqing, Chongqing Municipality, China

AusperBio Investigational Site

Fuzhou, Fujian, China

AusperBio Investigational Site

Xiamen, Fujian, China

AusperBio Investigational Site

Lanzhou, Gansu, China

AusperBio Investigational Site

Foshan, Guangdong, China

AusperBio Investigational Site

Guangzhou, Guangdong, China

AusperBio Investigational Site

Shenzhen, Guangdong, China

AusperBio Investigational Site

Liuchow, Guangxi, China

Key Dates

Start Date

August 12, 2025

Primary Completion Date

March 1, 2027

Completion Date

September 1, 2027

Last Updated

December 23, 2025

Enrollment

577

ACTUAL participants

Conditions

Chronic Hepatitis B

Interventions

AHB-137

DRUG

Placebo

DRUG

NA therapy

DRUG

Sponsors

Lead Sponsor

Ausper Biopharma Co., Ltd.

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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