Detecting HBsAg Reversion in Hepatitis B Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fahong Li
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Fahong Li
• Email: minelihong@163.com
• Phone: 13524212580

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.