Access HBV Assays - European Union (EU) Clinical Trial Protocol - (NCT04904835) | Clinical Trial Compass
CompletedNot Applicable
Access HBV Assays - European Union (EU) Clinical Trial Protocol -
France21,210 participantsStarted 2019-10-15
Plain-language summary
The objective of this protocol is the collection and testing of clinical samples to determine the clinical performance of the Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer.
The study will involve a multicenter, prospective and retrospective collection of samples, and testing of samples with the investigational Hepatitis B Virus assays as required per the European Union Common Technical Specification. All samples collected will be anonymized or pseudo-anonymised, leftover, remnant samples. Pseudo-anonymised collection of samples will require documented patient consent (oral or written).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject aged ≥ 18 years,
* Subject who has provided consent (oral or written) or sample collected under waiver
* With sufficient volume to perform clinical trial testing
* And belonging to one of the following enrollment groups:
* Unselected blood donors
* Hospitalized patients
* Presumed HBsAg positive patients by Confirmatory testing of a CE-marked assay
* Patients having recovered from natural HBV infection, presumed Anti-HBs positive (i.e. Anti-HBs and Anti-HBc Total positive by CE-marked assays)
* Patients having received HBV vaccination, presumed Anti-HBs positive (confirmed by testing at the time of enrollment, i.e. positive for Anti-HBs and negative for Anti-HBc by CE-marked assays).
* Presumed Anti-HBc Total positive patients by a CE-marked assay
* Presumed Anti-HBc IgM positive patients by a CE-marked assay with acute/recent HBV infection 8
* Presumed HBeAg positive patients by a CE-marked assay
* Presumed Anti-HBe positive patients by a CE-marked assay
* Patients with chronic HBV infection
Exclusion Criteria:
* Samples from subjects already included in the study\* (\* Patient can be included only once per HBV marker study, but can potentially be enrolled for several separate HBV marker studies.)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic accuracy measured as sensitivity and specificity