NCT07246889|Active Not RecruitingPhase 3DMC

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

Ausper Biopharma Co., Ltd.ClinicalTrials.gov

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1 other identifier

AB-10-8006

Study Type

interventional

Target

577

Locations

1 country

Sites

Timeline

RegisteredNov 2025

StartedAug 2025

CompletionOct 2027

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

577

participants targeted

Target at P75+ for phase_3

Timeline

18mo left

Started Aug 2025

Geographic Reach

1 country

28 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

Study Progress33%

Aug 2025Oct 2027

First Submitted

Initial submission to the registry

August 12, 2025

Completed

Same day until next milestone

Study Start

First participant enrolled

August 12, 2025

Completed

3 months until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2026

Expected

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

May 4, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

August 12, 2025

Last Update Submit

May 1, 2026

Conditions

Chronic Hepatitis B

Keywords

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

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 Outcomes (10)

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
+5 more secondary outcomes

Study Arms (2)

AHB-137

EXPERIMENTAL

Drug: AHB-137Drug: NA therapy

Placebo

PLACEBO COMPARATOR

Drug: PlaceboDrug: NA therapy

Interventions

PlaceboDRUG

Placebo will be injected weekly by subcutaneous injection.Two additional doses given on day 4 and day 11.

Placebo

NA therapyDRUG

NA will be the background therapy. After stopping the AHB-137 or placebo injection, continue for another 12 weeks.

AHB-137Placebo

AHB-137DRUG

AHB-137 will be injected weekly by subcutaneous injection. There are 2 leading doses on day 4 and day 11.

AHB-137

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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;
IU/mL \< HBsAg ≤ 3000 IU/mL, HBV DNA \< 100 IU/mL and liver function indicators meet the requirements;
Effective contraception as required.

You may not qualify if:

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.

Contact the study team to confirm eligibility.