Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550622
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Improved Sensitivity Detection of Serum HBsAg in Chronic Hepatitis B Patients Achieving Functional Cure and Its Association With HBsAg Reversion
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Whats 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 0005 IUml and current ARCHITECT HBsAg assay lower limit of detection for HBsAg is 005 IUml 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
The main question it aims to answer is
Whats 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 0005 IUml and current ARCHITECT HBsAg assay lower limit of detection for HBsAg is 005 IUml 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
Detailed Description:
In this study chronic hepatitis B patients who achieved HBsAg loss by current ARCHITECT HBsAg testing lower limit of detection for HBsAg is 005 IUml under interferon therapy and received consolidation therapy for 3 month after that were screened for eligibility Those who are willing to discontinue were enrolled in the study Patients were divided in two groups according to HBsAg levelsone with patients who were HBsAg-negative HBsAg0005 IUmLby HBsAg next assay and the other with patients who had HBsAg levels between 0005 IUmL and 005IUmL Patients were followed up for 48 weeks after discontinuation after HBsAg loss and HBsAg reversion rates in the two groups were analyzed and compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None