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Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04289428
Recruitment Status : Not yet recruiting
First Posted : February 28, 2020
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Kirby Institute

Brief Summary:
Evaluation of novel point of care Hepatitis B diagnostic assays.

Condition or disease Intervention/treatment
Hepatitis B Diagnostic Test: Xpert® HBV DNA fingerstick point of care assay Diagnostic Test: Point of Care ALT Diagnostic Test: Xpert® HBV DNA point of care assay from dried blood spot

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Biospecimen Retention:   Samples Without DNA
Dried blood spot samples of capillary blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04289428


Contacts
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Contact: Marianne Byrne +61293850900 mbyrne@kirby.unsw.edu.au

Locations
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Australia, New South Wales
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Contact: Gail Matthews    +61293850900    gmatthews@kirby.unsw.edu.au   
Sponsors and Collaborators
Kirby Institute
Investigators
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Principal Investigator: Gail Matthews, MBBS Kirby Institute
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Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT04289428    
Other Study ID Numbers: VHCRP2001
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kirby Institute:
Hepatitis B
Diagnostics
HBV DNA
ALT
Point of care
Dried blood spot
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections