Register a trial

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.



Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04289428
Ethics application status
Date submitted
25/02/2020
Date registered
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
Assessment method [1] 0 0
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
Assessment method [1] 0 0
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
Assessment method [2] 0 0
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
Sex
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
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2022
Actual
Sample size
Target
Accrual to date
Final
0
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
Government body
Name
Kirby Institute
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Gail Matthews, MBBS
Address 0 0
Kirby Institute
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04289428