Clinical trial NCT06550622: Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion
Official title: Improved Sensitivity Detection of Serum HBsAg in Chronic Hepatitis B Patients Achieving Functional Cure and Its Association With HBsAg Reversion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis B, Chronic
Keywords: HBsAg next assay
Functional cure
HBsAg loss
HBsAg reversion
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subject studied were HBsAg-negative, HBeAg-negative, and anti-HBe positive patients with chronic hepatitis B

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 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.

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 consolidation therapy for 3 month after that were screened for eligibility. Those who are willing to discontinue were enrolled in the study. Patients were divided in two groups according to HBsAg levels，one with patients who were HBsAg-negative （HBsAg\<0.005 IU/mL）by HBsAg next assay , and the other with patients who had HBsAg levels between 0.005 IU/mL and 0.05IU/mL. Patients were followed up for 48 weeks after discontinuation after HBsAg loss and HBsAg reversion rates in the two groups were analyzed and compared.

Eligibility 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.

Primary outcomes:
measure: HBsAg reversion rate
timeFrame: 48 weeks
Secondary outcomes:
measure: Proportion of patients who were HBsAg positive
timeFrame: 48 weeks
measure: HBsAg seroconversion rate
timeFrame: 48 weeks
measure: Surface antibody disappearing rates
timeFrame: 48 weeks
measure: Viral reactivation rate
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fahong Li
state: Shanghai
Study officials:
References: