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

NCT07246889 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 577

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

AHB-137

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

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.

Sponsors & Collaborators

  • Ausper Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • AusperBio Clinical Trials · AusperBio Investigational Site

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-12
Primary Completion
2026-12-18
Completion
2027-10-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07246889 on ClinicalTrials.gov