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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07146100

Enrollment

200

Registered

2025-08-28

Start date

2025-08-28

Completion date

2030-01-01

Last updated

2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Keywords

Hepatitis B, Chronic

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Percentage of participants maintained complete response(defined as HBsAg < 0.05IU/mL and HBV DNA < lower limit of quantification).	Up to 80 weeks

Secondary

Measure	Time frame	Description
Proportion of participants achieving and maintaining HBsAg<0.05 IU/mL.	Up to 80 weeks	—
Time to loss of HBsAg reversion.	Up to 80 weeks	—
Proportion and time of participants meeting certain test indicators after discontinuation of all CHB treatment.	Up to 80 weeks	—
Serum levels of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb,HBeAb.	Up to 80 weeks	—
Changes of the five-level five-dimensional health scale (EQ-5D-5L) instrument in participants compared with baseline.	Up to 80 weeks	—
Percentage of participants with mutations	Up to 80 weeks	—
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE), adverse events, hepatic endpoint events, deathsand clinically significant examination results.	Up to 80 weeks	Examination including laboratory examination, electrocardiogram (ECG) examination.
Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline.	Up to 80 weeks	—

Countries

China

Contacts

CONTACTLu

clinicaltrial@ausperbio.com0571-86959519

PRINCIPAL_INVESTIGATORJinlin Hou

Nanfang Hospital, Southern Medical University

PRINCIPAL_INVESTIGATORJunqi Niu

The First Hospital of Jilin University

Outcome results