Status:
RECRUITING
Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion
Lead Sponsor:
Huashan Hospital
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-65 years
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 curr...
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 0.05 IU/ml) under interferon therapy and received consolid...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients with hepatitis B cirrhosis in the compensated and decompensated stages: this includes patients with a clear history of cirrhosis (imaging or histological evidence) or Child-Pugh score ≥5 prior to NUC treatment, or who have had complications of the decompensated stage of cirrhosis, such as ascites, hepatic encephalopathy, or ruptured oesophago-gastric fundal varices bleeding;
- Combined HAV, HCV, HDV, HEV, HIV infections, 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 those with AFP greater than 100 ng/ml at screening and imaging suggestive of possible malignant hepatic occupancy; or patients with AFP greater than 100 ng/ml for a sustained period of 3 months;
- Patients with a combination of other malignant tumours (excluding those who have been cured);
- Patients with severe diseases or uncontrolled disease
- Those who are also participating in other clinical studies;
- Patients deemed unsuitable by the investigator to participate in this study.
Key Trial Info
Start Date :
August 10 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 10 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06550622
Start Date
August 10 2024
End Date
August 10 2027
Last Update
August 13 2024
Active Locations (1)
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1
Fahong Li
Shanghai, Shanghai Municipality, China, 200040