Improved Sensitivity Detection of Serum HBsAg in Chronic Hepatitis B Patients Achieving Functional Cure and Its Association With HBsAg Reversion

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• HBsAg-negative by Abbott's HBsAg Test and HBeAg-negative;

• Having serum specimens retained at baseline and at 48 weeks off treatment follow up;

• Being willing to follow up regularly for 1 year.

Locations
Other Locations
China
Fahong Li
RECRUITING
Shanghai
Contact Information
Primary
Fahong Li
minelihong@163.com
13524212580
Time Frame
Start Date: 2024-08-10
Estimated Completion Date: 2027-08-10
Participants
Target number of participants: 300
Treatments
Group A
CHB patients with HBsAg level\<0.005 IU/mL
Group B
CHB patients with 0.005 IU/mL\< HBsAg level \< 0.05 IU/mL
Related Therapeutic Areas
Sponsors
Leads: Huashan Hospital

This content was sourced from clinicaltrials.gov