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

NCT07146100 | Recruiting

• 1 other identifier: AB-10-8004
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Hepatitis B

Keywords

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

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

  Up to 80 weeks

Secondary Outcomes (8)

• 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

Study Arms (1)

Participants who have previously participated in AHB-137 clinical trials

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who have previously participated in AHB-137 clinical trials

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ausper Biopharma Co., Ltd.: lead

Study Sites (2)

AusperBio Investigational Site

Guangzhou, Guangdong, China

RECRUITING

AusperBio Investigational Site

Changchun, Jilin, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Jinlin Hou

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

• Junqi Niu

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu

CONTACT

0571-86959519; clinicaltrial@ausperbio.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 28, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)