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NCT Number: NCT07146100

Long-term Follow-up Study to Evaluate Participants With Chronic Hepatitis B (CHB) Previously Treated With AHB-137 Injection

This study is a prospective, open-label, multicenter long-term follow-up study to evaluate the durability of virologic response in subjects with chronic hepatitis B previously treated with AHB-137 injection.

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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

Observational

Primary location

AusperBio Investigational Site, Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Capable of giving informed consent.
  • Participants who have previously received at least one dose of AHB-137 and achieved the complete of partial response in the parent study without rescue medication and who maintained response until the End of Study (EoS) visit in their parent study.

Exclusion criteria

  • Participants who have/or are currently participating in another interventional clinical study since completing their treatment with AHB-137.
  • Suspected for cancer at screening or any condition required hospitalization during this study , or any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.

Treatment and study plan

Primary outcomes

  1. Percentage of participants maintained complete response(defined as HBsAg < 0.05IU/mL and HBV DNA < lower limit of quantification).

    Time frame: Up to 80 weeks

Secondary outcomes

  1. Proportion of participants achieving and maintaining HBsAg<0.05 IU/mL.

    Time frame: Up to 80 weeks

  2. Time to loss of HBsAg reversion.

    Time frame: Up to 80 weeks

  3. Proportion and time of participants meeting certain test indicators after discontinuation of all CHB treatment.

    Time frame: Up to 80 weeks

  4. Serum levels of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb,HBeAb.

    Time frame: Up to 80 weeks

  5. Changes of the five-level five-dimensional health scale (EQ-5D-5L) instrument in participants compared with baseline.

    Time frame: Up to 80 weeks

  6. Percentage of participants with mutations

    Time frame: Up to 80 weeks

  7. Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE), adverse events, hepatic endpoint events, deathsand clinically significant examination results.

    Time frame: Up to 80 weeks

    Examination including laboratory examination, electrocardiogram (ECG) examination.

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

    Time frame: Up to 80 weeks

Study contacts

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

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CONTACT

[email protected]

0571-86959519

Sponsors and collaborators

Lead sponsor

Ausper Biopharma Co., Ltd.

Industry

Registry information

Official study title

Prospective, Open-label, Multicenter Long-term Follow-up Study to Evaluate the Durability of Virologic Response in Participants With Chronic Hepatitis B Previously Treated With AHB-137 Injection

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Aug 28, 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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