Actively Recruiting
Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion
Led by Huashan Hospital · Updated on 2024-08-13
300
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Patients with hepatitis B cirrhosis in the compensated and decompensated stages, including history of cirrhosis or Child-Pugh score 6 prior to NUC treatment, or complications such as ascites, hepatic encephalopathy, or bleeding varices
- Combined infections with HAV, HCV, HDV, HEV, HIV, alcoholic liver disease, inherited metabolic liver disease, pharmacological liver disease, non-alcoholic fatty liver disease, autoimmune liver disease, and other chronic liver diseases
- Primary hepatocellular carcinoma or AFP greater than 100 ng/ml at screening or sustained for 3 months, or imaging suggestive of malignant hepatic lesions
- Patients with other malignant tumours (except those cured)
- Patients with severe or uncontrolled diseases
- Those participating in other clinical studies
- Patients deemed unsuitable by the investigator to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fahong Li
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
F
Fahong Li
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here