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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05144776




Registration number
NCT05144776
Ethics application status
Date submitted
22/11/2021
Date registered
3/12/2021
Date last updated
12/03/2024

Titles & IDs
Public title
Evaluation of Hepatitis B Virus (HBV) DNA Test as Point of Care Tool
Scientific title
Evaluation of Novel Hepatitis B DNA Test From Capillary Blood at the Point-of-care as a Tool to Enhance Clinical Management
Secondary ID [1] 0 0
VHCRP 2103
Universal Trial Number (UTN)
Trial acronym
HBVPOCT
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 - GeneXpert HBV DNA Viral Load Assay
Diagnosis / Prognosis - Dried Blood Spot HBV DNA test

Chronic hepatitis B - 300 patients diagnosed with chronic hepatitis B will be enrolled. A fingerstick HBV DNA test will be performed using the Xpert HBV Viral Load assay, and a dried blood spot sample will be collected which will be tested using a gold standard HBV DNA viral load assay. Both results will be compared against the HBV DNA viral load from standard of care venous blood using the gold standard HBV DNA viral load assy. Enrolment of HBV DNA undetectable participants will be capped at 100.


Diagnosis / Prognosis: GeneXpert HBV DNA Viral Load Assay
The Xpert venous blood HBV DNA viral load assay will be adapted to operate using fingerstick capillary blood samples.

Diagnosis / Prognosis: Dried Blood Spot HBV DNA test
HBV DNA viral load will be measured from a fingerstick capillary dried blood spot sample using a gold standard HBV DNA viral load assay
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assess performance of Xpert HBV DNA viral load assay using novel fingerstick capillary blood collection and HBV DNA viral load using fingerstick capillary Dried Blood Spot sample collection.
Timepoint [1] 0 0
At completion of enrolment
Secondary outcome [1] 0 0
Evaluate diagnostic performance of the novel tests by hepatitis B e-antigen status
Timepoint [1] 0 0
At completion of enrolment
Secondary outcome [2] 0 0
Evaluate diagnostic performance of the novel tests by HBV treatment status
Timepoint [2] 0 0
At completion of enrolment
Secondary outcome [3] 0 0
Evaluate diagnostic performance of the novel tests by HBV DNA levels
Timepoint [3] 0 0
At completion of enrolment

Eligibility
Key inclusion criteria
* Have voluntarily signed the informed consent form, 18 years of age or older, HBsAg positive
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Nil

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [3] 0 0
STORR Liver Centre Westmead Hospital - Sydney
Recruitment hospital [4] 0 0
Blacktown Hospital - Sydney
Recruitment hospital [5] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [6] 0 0
St Vincent's Hospital Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
2031 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Sydney
Recruitment postcode(s) [4] 0 0
2148 - Sydney
Recruitment postcode(s) [5] 0 0
2170 - Sydney
Recruitment postcode(s) [6] 0 0
3065 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a cross sectional observational study to asses the performance of two novel HBV DNA testing methodologies; a) dried blood spot sampling and b) fingerstick capillary blood using the Xpert® Hepatitis B Virus viral load assay. Both novel testing methodologies will be compared with venous blood tested using a gold standard HBV DNA assay. The sensitivity and specificity of the two novel testing will be evaluated.

HBV viral load tests are essential to guide antiviral treatment eligibility and effectiveness. However, many people are unable to access these tests, particularly those living in remote or limited resources settings given high cost, or unavailable infrastructure. Simple, affordable and accessible HBV viral load tests are required to increase global access to HBV testing and treatment to meet the WHO HBV elimination targets. The GeneXpert Diagnostic Systems, the most common molecular point-of-care platform globally, has the potential to provide simple and affordable HBV viral load tests. Dried Blood Spot testing is also an affordable and accessible testing methodology particularly suited to remote and resource limited settings. This proof-of-concept study will assess the feasibility and diagnostic performance of Xpert® HBV Viral Load test and Dried Blood Spot testing for the quantitation of HBV DNA from fingerstick capillary samples.
Trial website
https://clinicaltrials.gov/study/NCT05144776
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gail V Matthews, MBChB
Address 0 0
The Kirby Institute, University of New South Wales Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Elise Tu
Address 0 0
Country 0 0
Phone 0 0
+61 2 9385 0886
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05144776