Long-term Follow-up Study to Evaluate Participants With Chronic Hepatitis B (CHB) Previously Treated With AHB-137 Injection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Hepatitis B. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Primary outcome measures
- 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 outcome measures (8)
- Proportion of participants achieving and maintaining HBsAg<0.05 IU/mL. [Time frame: Up to 80 weeks]
- Time to loss of HBsAg reversion. [Time frame: Up to 80 weeks]
- Proportion and time of participants meeting certain test indicators after discontinuation of all CHB treatment. [Time frame: Up to 80 weeks]
- Serum levels of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb,HBeAb. [Time frame: Up to 80 weeks]
- Changes of the five-level five-dimensional health scale (EQ-5D-5L) instrument in participants compared with baseline. [Time frame: Up to 80 weeks]
- Percentage of participants with mutations [Time frame: 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. [Time frame: Up to 80 weeks]
- Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline. [Time frame: Up to 80 weeks]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 8 centers
- AusperBio Investigational Site — Chongqing
- AusperBio Investigational Site — Fuzhou
- AusperBio Investigational Site — Guangzhou
- AusperBio Investigational Site — Guangzhou
- AusperBio Investigational Site — Changhou
- AusperBio Investigational Site — Zhenjiang
- AusperBio Investigational Site — Changchun
- AusperBio Investigational Site — Hangzhou
Identifiers
NCT: NCT07146100 · AB-10-8004