NCT07137910

Brief Summary

This study is an open-label, multicenter phase II clinical study to evaluate the efficacy and safety of AHB-137 injection in participants with CHB previously treated with NA.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
13mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
Sep 2025Jun 2027

First Submitted

Initial submission to the registry

August 15, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

September 4, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 4, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

August 15, 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.

    At the 24th week after all treatment for CHB was discontinued

Secondary Outcomes (10)

  • Proportion of participants with persistent HBV DNA < LLOQ .

    During the 24-week period after discontinuation of all CHB treatment

  • Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ).

    Up to 60 weeks

  • Detection of the concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg.

    Up to 60 weeks

  • Relapse rate and time after discontinuation of NAs therapy.

    Up to 60 weeks

  • Changes of the score of Health-Related Quality of Life (HBQOL) in participants compared with baseline.

    Up to 60 weeks

  • +5 more secondary outcomes

Study Arms (2)

Relevant drug treatment group

EXPERIMENTAL
Drug: AHB-137

No relevant drug treatment group

EXPERIMENTAL
Drug: AHB-137

Interventions

AHB-137DRUG

AHB-137 will be injected

No relevant drug treatment groupRelevant drug treatment group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntarily participate in the study and sign the informed consent form;
  • years of age (including boundary values) ;
  • Body mass index met the requirements;
  • Participants with CHB who are HBsAg or HBV DNA positive for at least 6 months;
  • Meet the relevant requirements for prior medications;
  • HBsAg and HBV DNA and liver function indicators meet the requirements;
  • Effective contraception as required;

You may not qualify if:

  • Uncontrolled and stable clinically significant abnormalities other than a history of CHB infection;
  • Associated liver disease;
  • Any serious infection other than CHB infection requires intravenous anti-infective therapy;
  • HCV RNA positive, HIV antibody positive, syphilis positive;
  • Abnormal laboratory results;
  • Diseases associated with vascular inflammatory conditions;
  • QT interval corrected heart rate (Fridericia method) abnormal;
  • History of malignancy or ongoing assessment of possible malignancy;
  • History of allergies, or allergic constitution;
  • 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.

Sponsors & Collaborators

Study Sites (1)

AusperBio Investigational Site

Jilin, Changchun, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Junqi Niu

    The First Hospital of Jilin University

    PRINCIPAL INVESTIGATOR

  • Yanhua Ding

    The First Hospital of Jilin University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu

CONTACT

0571-86959519clinicaltrial@ausperbio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2025

First Posted

August 22, 2025

Study Start

September 4, 2025

Primary Completion (Estimated)

December 12, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

May 4, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)