Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays

November 22, 2021 updated by: Kirby Institute
Evaluation of novel point of care Hepatitis B diagnostic assays.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This study aims to evaluate the sensitivity of the following novel assays for evaluation of HBV infection and assessment of treatment eligibility;

  • GeneXpert HBV DNA via Fingerstick testing,
  • Dried Blood Spot based HBV DNA
  • Point of care ALT.

Study Type

Observational

Contacts and Locations

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

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St. Vincent's Hospital Sydney

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be enrolled into the study in two parts until the following sample sizes are met for the prospective samples Part A: At least 30 paired specimens of venous EDTA whole blood and DBS in treatment naive adults (HBV DNA detectable) Part B: At least 30 paired specimens of venous EDTA whole blood and DBS in HBV DNA undetectable adults on antiviral therapy

Description

Inclusion Criteria:

  1. Have voluntarily signed the informed consent form.
  2. 18 years of age or older.
  3. HBsAg positive
  4. Part A: Not currently on antiviral therapy for HBV and HBV DNA detectable OR Part B: Stable on HBV antiviral therapy for at least 3 months with HBV DNA < 20 IU/ml

Exclusion Criteria:

1) Inability or unwillingness to provide informed consent or abide by the requirements of the 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
Intervention / Treatment
A
Not currently on antiviral therapy for HBV and HBV DNA detectable
Diagnostic test: Xpert® HBV DNA fingerstick point of care assay
Xpert® HBV DNA point of care assay from finger-stick whole blood
Diagnostic test: Point of Care ALT
Point of Care ALT from finger-stick whole blood
Diagnostic test: Xpert® HBV DNA point of care assay from dried blood spot
Xpert® HBV DNA point of care assay from dried blood spot
B
Stable on HBV antiviral therapy for at least 3 months with HBV DNA < 20 IU/ml
Diagnostic test: Xpert® HBV DNA fingerstick point of care assay
Xpert® HBV DNA point of care assay from finger-stick whole blood
Diagnostic test: Point of Care ALT
Point of Care ALT from finger-stick whole blood
Diagnostic test: Xpert® HBV DNA point of care assay from dried blood spot
Xpert® HBV DNA point of care assay from dried blood spot

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of the Xpert® HBV DNA fingerstick point of care assay
Time Frame: Through study completion, an average of 1 year
To evaluate the sensitivity and specificity of the Xpert® HBV DNA point of care assay from finger-stick whole blood samples compared to plasma samples collected via venipuncture and tested on the Roche COBAS AmpliPrep/COBAS TaqMan HBV (CAP/CTM HBV) V2 assay.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of the point of care ALT
Time Frame: Through study completion, an average of 1 year
To evaluate the sensitivity and specificity of the point of care ALT assay from finger-stick whole blood samples compared to standard of care ALT collected via venepuncture.
Through study completion, an average of 1 year
Sensitivity and specificity of the Xpert® HBV DNA point of care assay on dried blood spots
Time Frame: Through study completion, an average of 1 year
To evaluate the sensitivity and specificity of the Xpert® HBV DNA point of care assay from dried blood spot samples compared to plasma samples collected via venipuncture and tested on the Roche COBAS AmpliPrep/COBAS TaqMan HBV (CAP/CTM HBV) V2 assay.
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Kirby Institute

Investigators

  • Principal Investigator: Gail Matthews, MBBS, Kirby Institute

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 (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

February 25, 2020

First Submitted That Met QC Criteria

February 26, 2020

First Posted (Actual)

February 28, 2020

Study Record Updates

Last Update Posted (Actual)

December 3, 2021

Last Update Submitted That Met QC Criteria

November 22, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VHCRP2001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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