Actively Recruiting
Improved Sensitivity Detection of Serum HBsAg in Chronic Hepatitis B Patients Achieving Functional Cure and Its Association With HBsAg Reversion
Led by Huashan Hospital · Updated on 2024-08-13
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand the rate at which hepatitis B surface antigen (HBsAg) returns in chronic hepatitis B patients who have tested negative for HBsAg after treatment. The study compares a new, more sensitive HBsAg NEXT assay with the current ARCHITECT HBsAg assay to measure HBsAg reversion at 48 weeks after stopping treatment. It focuses on patients who have achieved functional cure under interferon therapy and completed consolidation therapy.
CONDITIONS
Brief Title
Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- HBsAg-negative by Abbott's HBsAg Test and HBeAg-negative
- Have serum specimens retained at baseline and at 48 weeks off treatment follow-up
- Willing to follow up regularly for 1 year
You will not qualify if you...
- Patients with hepatitis B cirrhosis in compensated or decompensated stages
- Patients with combined infections such as HAV, HCV, HDV, HEV, HIV, or other chronic liver diseases
- Patients with primary hepatocellular carcinoma or high AFP levels suggesting malignancy
- Patients with other malignant tumors (unless cured)
- Patients with severe or uncontrolled diseases
- Participants in other clinical studies
- Patients deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 48 weeks
Participants who have discontinued therapy after achieving HBsAg loss are observed to monitor HBsAg reversion and related outcomes.
Regular follow-up visits over 48 weeks
Trial Site Locations
Total: 1 location
1
Fahong Li
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
F
Fahong Li
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
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