Detecting HBsAg Reversion in Hepatitis B Patients
Improved Sensitivity Detection of Serum HBsAg in Chronic Hepatitis B Patients Achieving Functional Cure and Its Association With HBsAg Reversion
This study is testing how well a new blood test can find if hepatitis B patients who have stopped treatment might have their virus levels come back after being cleared.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Huashan Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06550622 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the rate of HBsAg reversion in patients who have achieved HBsAg loss after treatment for chronic hepatitis B. It utilizes the HBsAg NEXT assay, which has improved sensitivity compared to the current ARCHITECT HBsAg assay. Patients who are HBsAg-negative will be monitored for 48 weeks after discontinuing treatment, and their HBsAg levels will be analyzed to determine the reversion rates. The study compares the effectiveness of the two assays in detecting HBsAg reversion.
Who should consider this trial
Good fit: Ideal candidates are chronic hepatitis B patients who have achieved HBsAg loss and are HBsAg-negative by the Abbott's HBsAg Test.
Not a fit: Patients with advanced liver disease, such as cirrhosis or other chronic liver conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better monitoring and understanding of HBsAg reversion, potentially improving management strategies for chronic hepatitis B patients.
How similar studies have performed: While there have been studies on HBsAg detection, this approach using the HBsAg NEXT assay for reversion rates is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Fahong Li — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Fahong Li
- Email: minelihong@163.com
- Phone: 13524212580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.