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

Ausper Biopharma Co., Ltd.200 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Chronic Hepatitis B

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (37)

Outcomes

Primary Outcomes

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

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.

Examination including laboratory examination, electrocardiogram (ECG) examination.

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

Central Contacts

CONTACT

0571-86959519 clinicaltrial@ausperbio.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.