Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays
NCT ID: NCT04289428
Last Updated: 2021-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2022-01-31
2022-10-31
Brief Summary
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Detailed Description
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* GeneXpert HBV DNA via Fingerstick testing,
* Dried Blood Spot based HBV DNA
* Point of care ALT.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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A
Not currently on antiviral therapy for HBV and HBV DNA detectable
Xpert® HBV DNA fingerstick point of care assay
Xpert® HBV DNA point of care assay from finger-stick whole blood
Point of Care ALT
Point of Care ALT from finger-stick whole blood
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
Xpert® HBV DNA fingerstick point of care assay
Xpert® HBV DNA point of care assay from finger-stick whole blood
Point of Care ALT
Point of Care ALT from finger-stick whole blood
Xpert® HBV DNA point of care assay from dried blood spot
Xpert® HBV DNA point of care assay from dried blood spot
Interventions
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Xpert® HBV DNA fingerstick point of care assay
Xpert® HBV DNA point of care assay from finger-stick whole blood
Point of Care ALT
Point of Care ALT from finger-stick whole blood
Xpert® HBV DNA point of care assay from dried blood spot
Xpert® HBV DNA point of care assay from dried blood spot
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Kirby Institute
OTHER_GOV
Responsible Party
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Principal Investigators
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Gail Matthews, MBBS
Role: PRINCIPAL_INVESTIGATOR
Kirby Institute
Locations
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St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Countries
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Other Identifiers
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VHCRP2001
Identifier Type: -
Identifier Source: org_study_id