Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

August 8, 2024 updated by: Jiming Zhang, Huashan Hospital

Improved Sensitivity Detection of Serum HBsAg in Chronic Hepatitis B Patients Achieving Functional Cure and Its Association With HBsAg Reversion

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Recruiting
        • Fahong Li
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group A
CHB patients with HBsAg level<0.005 IU/mL
Group B
CHB patients with 0.005 IU/mL< HBsAg level < 0.05 IU/mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HBsAg reversion rate
Time Frame: 48 weeks
HBsAg reversion rate in patients with HBsAg loss by Abbott's HBsAg next assay at week 48 off treatment
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who were HBsAg positive
Time Frame: 48 weeks
Proportion of patients who were HBsAg positive by HBsAg Next assay in those who were HBsAg negative by ARCHITECT HBsAg test.
48 weeks
HBsAg seroconversion rate
Time Frame: 48 weeks
HBsAg seroconversion rate at 48 weeks off treatment follow-up in patients with HBsAg loss
48 weeks
Surface antibody disappearing rates
Time Frame: 48 weeks
Surface antibody disappearing rates at 48 Weeks off treatment Follow-up in Patients with HBsAg loss
48 weeks
Viral reactivation rate
Time Frame: 48 weeks
Viral reactivation rate (HBV DNA > 20 IU/ml) at 48 weeks off treatment in patients with HBsAg loss
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 10, 2024

Primary Completion (Estimated)

August 10, 2027

Study Completion (Estimated)

August 10, 2027

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 13, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-700

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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