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NCT Number: NCT07137910

A Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntarily participate in the study and sign the informed consent form;
  • 18-65 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;

Exclusion criteria

  • 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.

Treatment and study plan

AHB-137

Drug

AHB-137 will be injected

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.

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

Secondary outcomes

  1. Proportion of participants with persistent HBV DNA < LLOQ .

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

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

    Time frame: Up to 60 weeks

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

    Time frame: Up to 60 weeks

  4. Relapse rate and time after discontinuation of NAs therapy.

    Time frame: Up to 60 weeks

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

    Time frame: Up to 60 weeks

  6. Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline.

    Time frame: Up to 60 weeks

  7. Number and percentage of participants with detectable anti-drug antibodies (ADA).

    Time frame: Up to 60 weeks

  8. Sequencing of the Viral DNA and/or viral RNA analysis for detection of drug resistance in the target region of AHB-137.

    Time frame: Up to 60 weeks

  9. Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.

    Time frame: Up to 60 weeks

    Examination including laboratory examination, electrocardiogram (ECG) examination.

  10. Plasma concentrations of AHB-137.

    Time frame: Up to 60 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Ausper Biopharma Co., Ltd.

Industry

Registry information

Official study title

An Open-label, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B Previously Treated With Nucleos (t) Ide Analogues (NA)

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 22, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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