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Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion
Sponsor: Huashan Hospital
Summary
The goal of this observational study is to learn about the HBsAg reversion rate at 48 weeks off treatment in HBsAg-negative patients by HBsAg NEXT assay which has improved sensitivity compared to current ARCHITECT HBsAg Assay. The main question it aims to answer is: What's the HBsAg reversion rate at 48 weeks off treatment in HBsAg-negative patients by HBsAg NEXT assay? HBsAg NEXT assay technology (lower limit of detection for HBsAg is 0.005 IU/ml) and current ARCHITECT HBsAg assay (lower limit of detection for HBsAg is 0.05 IU/ml) are applied for HBsAg detection in patients achieving functional cure, and to compare the difference in HBsAg reversion rate 48 weeks off treatment under the two types of criteria.
Official title: Improved Sensitivity Detection of Serum HBsAg in Chronic Hepatitis B Patients Achieving Functional Cure and Its Association With HBsAg Reversion
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2024-08-10
Completion Date
2027-08-10
Last Updated
2024-08-13
Healthy Volunteers
No
Conditions
Locations (1)
Fahong Li
Shanghai, Shanghai Municipality, China