Study Stopped
Funding not awarded. A new study design and protocol have been submitted
Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays
1 other identifier
observational
N/A
1 country
1
Brief Summary
Evaluation of novel point of care Hepatitis B diagnostic assays.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2020
CompletedFirst Posted
Study publicly available on registry
February 28, 2020
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedDecember 3, 2021
November 1, 2021
6 months
February 25, 2020
November 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity and specificity of the Xpert® HBV DNA fingerstick point of care assay
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 Outcomes (2)
Sensitivity and specificity of the point of care ALT
Through study completion, an average of 1 year
Sensitivity and specificity of the Xpert® HBV DNA point of care assay on dried blood spots
Through study completion, an average of 1 year
Study Arms (2)
A
Not currently on antiviral therapy for HBV and HBV DNA detectable
B
Stable on HBV antiviral therapy for at least 3 months with HBV DNA \< 20 IU/ml
Interventions
Xpert® HBV DNA point of care assay from finger-stick whole blood
Xpert® HBV DNA point of care assay from dried blood spot
Eligibility Criteria
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
You may qualify if:
- Have voluntarily signed the informed consent form.
- years of age or older.
- HBsAg positive
- 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
You may not qualify if:
- \) Inability or unwillingness to provide informed consent or abide by the requirements of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kirby Institutelead
Study Sites (1)
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
Biospecimen
Dried blood spot samples of capillary blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gail Matthews, MBBS
Kirby Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2020
First Posted
February 28, 2020
Study Start
January 1, 2022
Primary Completion
July 1, 2022
Study Completion
October 1, 2022
Last Updated
December 3, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share