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Recruiting NCT07137910

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

Phase II Interventional Chronic Hepatitis B

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AHB-137, NA therapy.
Who it may be relevant to
Registry conditions: Chronic Hepatitis B. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-Label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Low-HBsAg Chronic Hepatitis B

Overview

This is an open-label, multicenter, Phase 2 study designed to evaluate the efficacy and safety of AHB-137 injection in participants with chronic hepatitis B (CHB) with low hepatitis B surface antigen (HBsAg) levels.

Interventions

  • Drug AHB-137
    AHB-137 will be injected
  • Drug NA therapy
    NA will be usede.

Primary outcome measures

  • 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 outcome measures (10)
  • Proportion of participants with persistent HBV DNA < LLOQ . [Time frame: 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). [Time frame: Up to 60 weeks]
  • Detection of the concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg. [Time frame: Up to 60 weeks]
  • Relapse rate and time after discontinuation of NAs therapy. [Time frame: Up to 60 weeks]
  • Changes of the score of Health-Related Quality of Life (HBQOL) in participants compared with baseline. [Time frame: Up to 60 weeks]
  • 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]
  • Number and percentage of participants with detectable anti-drug antibodies (ADA). [Time frame: Up to 60 weeks]
  • 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]
  • 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]
  • Plasma concentrations of AHB-137. [Time frame: Up to 60 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 12 centers
  • AusperBio Investigational Site — Beijing
  • AusperBio Investigational Site — Jilin City
  • AusperBio Investigational Site — Chongqing
  • AusperBio Investigational Site — Chongqing
  • AusperBio Investigational Site — Xiamen
  • AusperBio Investigational Site — Guangzhou
  • AusperBio Investigational Site — Shenzhen
  • AusperBio Investigational Site — Nanning
  • … and 4 more centers

Identifiers

NCT: NCT07137910 · AB-10-8009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗