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Active, Not Recruiting

NCT Number: NCT07246889

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

AusperBio Investigational Site, Hefei, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

AHB-137

Drug

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

Placebo

Drug

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

NA therapy

Drug

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

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: 24 weeks after discontinuation of all CHB treatment

Secondary outcomes

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

    Time frame: 24 weeks after discontinuation of all CHB treatment

  2. Proportion of participants with persistent HBsAg < LOD and HBV DNA < LLOQ

    Time frame: Up to 60 weeks

  3. Concentration of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb,HBeAg, HBeAb

    Time frame: Up to 60 weeks

  4. Relapse rate after discontinuation of NAs therapy.

    Time frame: Up to 60 weeks

  5. Safety: Number and percentage of participants with detectable anti-drug antibodies (ADA).

    Time frame: Up to 60 weeks

  6. 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

  7. Plasma concentrations of AHB-137.

    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. Change from baseline in EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) scores in participants with HBV infection.

    Time frame: Up to 60 weeks

    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

  10. Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline.

    Time frame: Up to 60 weeks

    This scale has 31 items, including 7 dimensions: psychological status, expected anxiety, vitality, shame, infectivity, health vulnerability, and viral response. Each item is scored on a 5-point scale, with higher scores indicating a more severe impact of hepatitis B on quality of life.

Sponsors and collaborators

Lead sponsor

Ausper Biopharma Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 24, 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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