An interventional study of TruPlex HIV/HepB/Syphilis Rapid Test in HIV1 Infection, HIV 2 Infection and Syphilis Infection, sponsored by bioLytical Laboratories. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
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 5th largest by planned enrollment of the 42 interventional ones that give a count, is one of 2 that started in 2026, is one of 5 with no phase, and was the 50th 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:
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+
Epigenic Therapeutics, Inc · Sites in Australia, China, New Zealand
Ages 18–65
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 · healthy volunteers too.
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. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 500 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.
This tab as a report to print or save as PDF → With an account.
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.
To evaluate the clinical performance of each analyte (HIV, HBsAg, and Syphilis) on the TruPlex HIV/HepB/Syphilis Rapid Test (TruPlex Test) using capillary blood (fingerstick), EDTA whole blood, EDTA-plasma, and SST-serum samples collected by trained operators at point-of-care settings. Additionally, to evaluate the usability of the TruPlex test through: structured usability assessments, via a questionnaire, completed by trained operators in point-of-care settings.
A prospective study to evaluate TruPlex Test when used by trained users.
Non-invasive samples (fingerstick, EDTA whole blood, EDTA-plasma, and SST-serum) will be collected and tested on TruPlex Tests by healthcare professionals. The collected capillary and EDTA whole blood samples will be tested on TruPlex Tests. Subsequently, EDTA whole blood and SST whole blood samples will be further processed to obtain plasma and serum, respectively, for testing on the TruPlex. Additional venous whole blood samples will be collected and sent to the National Serology Reference Laboratory (NSRL) for confirmatory testing (HIV, Syphilis and HBsAg) using approved on-the-market assays. Any remaining samples will be stored for further discrepancy testing or future research use.
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.
Subject is getting tested for , and/or Syphilis, and/or 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.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care settings will be tested on the TruPlex HIV/HepB/Syphilis Rapid Test.
Device: TruPlex HIV/HepB/Syphilis Rapid Test
A rapid in vitro diagnostic device designed to determine HIV, Syphilis and Hep B infection status.
Performance Evaluation
The study will assess the sensitivity and specificity of the TruPlex Test for detecting: * HIV-1 and HIV-2 antibodies * Syphilis antibodies * Hepatitis B surface antigen (HBsAg) Capillary blood, EDTA whole blood, EDTA-plasma and SST-serum samples will be tested using the TruPlex Test. Performance will be compared against approved, current on-market assays for the detection of HIV 1/2 antibodies, Syphilis antibodies, and HBsAg.
Time frame: 6 months
Usability Evaluation
Usability will be determined via a questionnaire completed by trained personnel who used the device during testing. The usability questionnaire will use a scale of one (1) to 5 (1 - very difficult/very unlikely to 5 - very easy/very likely), with a rating of 3 being satisfactory.
Time frame: 6 months
Started May 2026 (actual). Primary completion is estimated for Jan 2027, 7 months after the start.
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 planned 7 months is below that.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → May 2026, on Nov 4, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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