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Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

ConditionHepatitis B, Chronic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorHuashan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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);

Trial population

The subject studied were HBsAg-negative, HBeAg-negative, and anti-HBe positive patients with chronic hepatitis B

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 2 trial groups
Group A: Group A
Group B: Group B

Trial outcomes

Primary outcomes

1

HBsAg reversion rate

HBsAg reversion rate in patients with HBsAg loss by Abbott's HBsAg next assay at week 48 off treatment

Time frame
48 weeks

Secondary outcomes

1

Proportion of patients who were HBsAg positive

Proportion of patients who were HBsAg positive by HBsAg Next assay in those who were HBsAg negative by ARCHITECT HBsAg test.

Time frame
48 weeks
2

HBsAg seroconversion rate

HBsAg seroconversion rate at 48 weeks off treatment follow-up in patients with HBsAg loss

Time frame
48 weeks
3

Surface antibody disappearing rates

Surface antibody disappearing rates at 48 Weeks off treatment Follow-up in Patients with HBsAg loss

Time frame
48 weeks
4

Viral reactivation rate

Viral reactivation rate (HBV DNA \> 20 IU/ml) at 48 weeks off treatment in patients with HBsAg loss

Time frame
48 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Huashan Hospital

Lead sponsor

Source ClinicalTrials.gov
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