Official Title: Evaluation of Novel Hepatitis B DNA Test From Capillary Blood at the Point-of-care as a Tool to Enhance Clinical Management
Actual Study Start Date: November 17, 2022
Estimated Primary Completion Date: December 1, 2024
Estimated Study Completion Date: December 1, 2026
Study Description:
This study will be a cross-sectional observational study and will assess the performance of a novel fingerstick HBV Viral Load and Dried Blood Spot tests within a total of 300 participants who will be recruited across a network of hepatitis clinics in Sydney, Australia. No treatment will be administered as part of this study.
The Xpert HBV cartridge will be adapted to use fingerstick capillary blood instead of processed whole blood, and it’s performance measured against a gold standard venous blood HBV DNA assay. Dried Blood Spot HBV DNA testing performance will also be measured against the gold standard venous blood HBV DNA assay.
Secondary objectives of the study are to: 1) evaluate diagnostic performance of the Xpert® HBV Viral Load assay compared to standard of care testing, by patients’ hepatitis B e-antigen status (among e-antigen positive and e-antigen negative patients). 2) Evaluate diagnostic performance of the Xpert® HBV Viral Load assay compared to standard of care testing, by HBV treatment status (among treatment naïve patients and those receiving treatment). 3) Evaluate diagnostic performance of the Xpert® HBV Viral Load assay compared to standard of care testing, by HBV DNA levels (among patients with HBV DNA <20 IU/mL; between 20 and 2,000 IU/mL, between 2,000 and 20,000 IU/mL; between 20,000 and 200,000 IU/mL; and >200,000 IU/mL).
Eligibility Criteria: Have voluntarily signed the informed consent form, 18 years of age or older, HBsAg positive
Recruiting Sites & Contacts:
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St Vincent’s Hospital Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Gail Matthews, Professor 02 83823607 [gmatthews@kirby.unsw.edu.au]
Contact: Rebecca Hickey 02 8382 3607 [rebecca.hickey@svha.org.au] -
Prince of Wales Hospital Recruiting
Sydney, New South Wales, Australia, 2031
Contact: Renier Lagunday 02 93823405 [renier.lagunday@health.nsw.gov.au]
Principal Investigator: Marianne Martinello, Dr -
Liverpool Hospital Recruiting
Sydney, New South Wales, Australia, 2170
Contact: Georgia Crowley 02 8738 6215 [georgia.crowley1@health.nsw.gov.au]
Contact: Julia Di Girolamo 02 8738 6218 [julia.digirolamo@health.nsw.gov.au]
Principal Investigator: Miriam Levy, Assoc Prof
Sponsors and Collaborators: Kirby Institute
Trial Registration Information: Evaluation of Hepatitis B Virus (HBV) DNA Test as Point of Care Tool - Full Text View - ClinicalTrials.gov