An interventional study of iStatis HBsAg Test in Hepatitis B and Hepatitis B Infection, sponsored by bioLytical Laboratories. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by bioLytical Laboratories · Not applicable, Interventional, and Screening
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Among 50 studies in Hepatitis B with a site in Australia — 6 open to participants now, 9 under way, none of them phase 3. Hepatitis B · Australia.
Among the 50 studies in Hepatitis B with a site in Australia, this one is the 17th largest by enrollment of the 42 interventional ones that give a count, is one of 4 that started in 2024, is one of 5 with no phase, and was the 44th registered.
1,046 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
Browse Hepatitis B studies →6 of the 50 studies in Hepatitis B with a site in Australia are open now. Recruiting first, the newest first:
bioLytical Laboratories · Sites in Australia
Ages 18+ · Healthy volunteers
AusperBio Therapeutics Inc. · Sites in Australia, China, Japan and 4 more countries
Ages 18–65
GigaGen, Inc. · Sites in Australia, United States, Hong Kong and 2 more countries
Ages 18+
Kirby Institute · Sites in Australia
Ages 18+ · Healthy volunteers
Kirby Institute · Sites in Australia
Ages 18+
A study can be open while its sites in Australia have not opened yet or have stopped. Only those recruiting at a site in Australia →
Of the 80 Hepatitis B studies recruiting now, 40 (50%) set no upper age limit and 35 (44%) stop at 75 or younger; 14 take children under 18; 20 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
50 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 14 · Phase 3 9 · Phase 4 4
First in 1999; this study’s year is marked. 4 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 175 is above the median of 145 across 756 interventional studies indexed under Hepatitis B.
Median enrollment 103 across the 42 interventional studies, 186 across the 6 observational. Of the 38 that completed or were terminated, 16 (42%) have results posted.
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40 of 50 have an industry lead sponsor. The 10 most frequent:
bioLytical Laboratories is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
bioLytical Laboratories has 4 studies filed under Hepatitis B — fewer than ten, so there is no comparison to draw.
4 of the studies in Hepatitis B with a site in Australia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07569913bioLytical LaboratoriesA Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test | 2027-01-01 |
| NCT07059403Chimivac INCA Study of SN2001 Dose, Safety & Immunogenicity in Healthy Adults | 2027-04 |
| NCT06537414GlaxoSmithKlineA Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB) | 2027-05-31 |
| NCT06661148Epigenic Therapeutics, IncStudy of EPI-003 in Select Nucleos(t)Ide Analogue-Treated, Chronic Hepatitis B Patients | 2027-06-30 |
Add all 4 to your calendar (.ics) → With an account.
Among the 50 studies in Hepatitis B with a site in Australia, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and EDTA venipuncture whole blood are collected by a healthcare professional. The collected samples of capillary and EDTA whole blood are tested on iStatis and EDTA whole blood sample will be processed to obtain serum and plasma samples to be tested on the iStatis. An aliquot of the collected serum sample will be shipped to the central laboratory for confirmatory testing. The results from iStatis HBsAg Test results will not be used for patient management decisions.
From each enrolled patient, a total of 2 different blood samples (capillary and venous whole blood) will be collected, processed, and categorized under the following categories:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients/subjects (males, females, and pregnant women) getting tested for for one or more of the following reasons:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
capillary (fingerstick) blood, EDTA venous whole blood, serum and plasma samples will be tested on iStatis HBsAg Test
Device: iStatis HBsAg Test
Either serum or plasma samples will undergo reference lab testing using DiaSorin Liaison XL Murex HBsAg Quant Assay and DiaSorin Murex HBsAg Confirmatory assay
capillary (fingerstick) blood, EDTA venous whole blood, serum and plasma samples are tested on the iStatis HBsAg Test
Performance
To evaluate the performance of the iStatis HBsAg POC test with the RT-PCR test at the point of care sites by a healthcare professional.
Time frame: 3 Months
Sensitivity and Specificity
To assess the sensitivity and specificity of the iStatis HBsAg POC test with four different sample types.
Time frame: 3 Months
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2024 to primary completion in Jul 2024, 2 months.
Of 68 interventional studies with no phase under Hepatitis B, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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