Long-term follow-up of people with chronic hepatitis B after 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
This follow-up will see how long viral control lasts in people with chronic hepatitis B who had a complete or partial response to AHB-137 injection.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ausper Biopharma Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Trial ID | NCT07146100 on ClinicalTrials.gov |
What this trial studies
This is a prospective, open-label, multicenter long-term follow-up of people with chronic hepatitis B who previously received AHB-137 and achieved a complete or partial response without rescue medication. Participants who maintained response through the parent study End of Study visit will be followed for durability of virologic response with periodic visits and viral monitoring. The study is observational with no additional investigational interventions and excludes those who have enrolled in other interventional trials or who have conditions that contraindicate participation. Visits will be conducted at AusperBio investigational sites in Guangzhou and Changchun, China.
Who should consider this trial
Good fit: Ideal candidates are people with chronic hepatitis B who previously received at least one dose of AHB-137, achieved and maintained a complete or partial response through their parent study End of Study visit, can give informed consent, and are not enrolled in other interventional trials.
Not a fit: Patients who never received AHB-137, did not respond or required rescue medication in the parent study, or who have active cancer or other contraindicating medical conditions are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, this could show how long AHB-137 keeps the virus under control and help doctors plan follow-up and treatment.
How similar studies have performed: Long-term follow-ups of other hepatitis B therapies have often shown durable viral suppression in responders, but long-term data specific to AHB-137 are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong and 1 other locations
- AusperBio Investigational Site — Guangzhou, Guangdong, China (Recruiting)
- AusperBio Investigational Site — Changchun, Jilin, China (Recruiting)
Study contacts
- Principal investigator: Jinlin Hou — Nanfang Hospital, Southern Medical University
- Study coordinator: Lu
- Email: clinicaltrial@ausperbio.com
- Phone: 0571-86959519
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.