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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04289428




Registration number
NCT04289428
Ethics application status
Date submitted
25/02/2020
Date registered
28/02/2020
Date last updated
28/02/2020

Titles & IDs
Public title
Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays
Scientific title
Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays
Secondary ID [1] 0 0
VHCRP2001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Xpert® HBV DNA fingerstick point of care assay
Diagnosis / Prognosis - Point of Care ALT
Diagnosis / Prognosis - Xpert® HBV DNA point of care assay from dried blood spot

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


Diagnosis / Prognosis: Xpert® HBV DNA fingerstick point of care assay
Xpert® HBV DNA point of care assay from finger-stick whole blood

Diagnosis / Prognosis: Point of Care ALT
Point of Care ALT from finger-stick whole blood

Diagnosis / Prognosis: Xpert® HBV DNA point of care assay from dried blood spot
Xpert® HBV DNA point of care assay from dried blood spot

Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Through study completion, an average of 1 year
Secondary outcome [1] 0 0
Sensitivity and specificity of the point of care ALT - 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.
Timepoint [1] 0 0
Through study completion, an average of 1 year
Secondary outcome [2] 0 0
Sensitivity and specificity of the Xpert® HBV DNA point of care assay on dried blood spots - 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.
Timepoint [2] 0 0
Through study completion, an average of 1 year

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Inability or unwillingness to provide informed consent or abide by the requirements of
the study.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Evaluation of novel point of care Hepatitis B diagnostic assays.
Trial website
https://clinicaltrials.gov/show/NCT04289428
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gail Matthews, MBBS
Address 0 0
Kirby Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Marianne Byrne
Address 0 0
Country 0 0
Phone 0 0
+61293850900
Fax 0 0
Email 0 0
mbyrne@kirby.unsw.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04289428