Hepatitis BNCT04289428
Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays
An observational study of Hepatitis B, run by Kirby Institute at 1 site in Australia.
Trial summary
Evaluation of novel point of care Hepatitis B diagnostic assays. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Xpert® HBV DNA fingerstick point of care assay, Point of Care ALT and Xpert® HBV DNA point of care assay from dried blood spot
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2022to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- Have voluntarily signed the informed consent form.
- 18 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
Who cannot join
- 1) Inability or unwillingness to provide informed consent or abide by the requirements of the study.
Trial locations and contacts
1 site in 1 country.
Australia1 site
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
About this study
Evaluation of novel point of care Hepatitis B diagnostic assays.
Read the detailed description
This study aims to evaluate the sensitivity of the following novel assays for evaluation of HBV infection and assessment of treatment eligibility;
- GeneXpert HBV DNA via Fingerstick testing,
- Dried Blood Spot based HBV DNA
- Point of care ALT.
- Conditions
- Hepatitis B
- Being tested
- Xpert® HBV DNA fingerstick point of care assay, Point of Care ALT, Xpert® HBV DNA point of care assay from dried blood spot
- Keywords
- Hepatitis B, Diagnostics, HBV DNA, ALT, Point of care, Dried blood spot
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpert® HBV DNA fingerstick point of care assayDiagnostic test
Xpert® HBV DNA point of care assay from finger-stick whole blood
Point of Care ALTDiagnostic test
Point of Care ALT from finger-stick whole blood
Xpert® HBV DNA point of care assay from dried blood spotDiagnostic test
Xpert® HBV DNA point of care assay from dried blood spot
| Study group | Role | What they receive |
|---|---|---|
| A | Not currently on antiviral therapy for HBV and HBV DNA detectable Receives: Diagnostic Test: Xpert® HBV DNA fingerstick point of care assay; Diagnostic Test: Point of Care ALT; Diagnostic Test: Xpert® HBV DNA point of care assay from dried blood spot | |
| B | Stable on HBV antiviral therapy for at least 3 months with HBV DNA < 20 IU/ml Receives: Diagnostic Test: Xpert® HBV DNA fingerstick point of care assay; Diagnostic Test: Point of Care ALT; Diagnostic Test: Xpert® HBV DNA point of care assay from dried blood spot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
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.
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study startJan 2022 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: Funding not awarded. A new study design and protocol have been submitted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gail Matthews, MBBS, Principal investigator, Kirby Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289428
- Sponsor's protocol ID
- VHCRP2001
- Status last verified
- Nov 2021
- First submitted
- 25 Feb 2020
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays
- ClinicalTrials.gov ID
- NCT04289428
- Acronym / sponsor ID
- VHCRP2001
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, Diagnostics, HBV DNA, ALT, Point of care, Dried blood spot
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding not awarded. A new study design and protocol have been submitted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of novel point of care Hepatitis B diagnostic assays.
Detailed description
This study aims to evaluate the sensitivity of the following novel assays for evaluation of HBV infection and assessment of treatment eligibility;
- GeneXpert HBV DNA via Fingerstick testing,
- Dried Blood Spot based HBV DNA
- Point of care ALT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Diagnostic Test: Xpert® HBV DNA fingerstick point of care assay, Diagnostic Test: Point of Care ALT, Diagnostic Test: Xpert® HBV DNA point of care assay from dried blood spotNot currently on antiviral therapy for HBV and HBV DNA detectable |
| B | – | Diagnostic Test: Xpert® HBV DNA fingerstick point of care assay, Diagnostic Test: Point of Care ALT, Diagnostic Test: Xpert® HBV DNA point of care assay from dried blood spotStable on HBV antiviral therapy for at least 3 months with HBV DNA < 20 IU/ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (4 listed)
- Have voluntarily signed the informed consent form.
- 18 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
Key exclusion criteria (1 listed)
- 1) Inability or unwillingness to provide informed consent or abide by the requirements of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xpert® HBV DNA fingerstick point of care assayXpert® HBV DNA point of care assay from finger-stick whole blood | Diagnostic test | A, B |
| Point of Care ALTPoint of Care ALT from finger-stick whole blood | Diagnostic test | A, B |
| Xpert® HBV DNA point of care assay from dried blood spotXpert® HBV DNA point of care assay from dried blood spot | Diagnostic test | A, B |
Primary outcome
Sensitivity and specificity of the Xpert® HBV DNA fingerstick point of care assay
Time frame: Through study completion, an average of 1 year
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.
2 secondary outcomes
Sensitivity and specificity of the point of care ALT
Time frame: Through study completion, an average of 1 year
Sensitivity and specificity of the Xpert® HBV DNA point of care assay on dried blood spots
Time frame: Through study completion, an average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail Matthews, MBBS principal investigator
Kirby Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by Kirby Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the Xpert® HBV DNA fingerstick point of care assay (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.