Hepatitis BDiVHeBNCT04109625
Preliminary Validation of an in Vitro Diagnosis-medical Device for Hepatitis B Screening
A study testing Demonstrator MAGIA in people with Hepatitis B and Healthy, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The principal objective of the study is to perform a first step of technical adjustment and preliminary validation of a diagnostic test for hepatitis B (HBsAntigen, anti-HBs Antibody and anti-HBc Antibody) on capillary blood with the device under study in non-immunized subjects against hepatitis B, in subjects with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Healthy, Diagnoses Disease
- What is being tested?
- Demonstrator MAGIA
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2019to 13 May 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group 1: HBsAg negative, Anti HBc negative, Anti HBs negative, during a laboratory assay on serum
- Group 2: HBsAg negative, Anti HBc negative, Anti HBs positive, during a laboratory assay on serum
- Group 3: HBsAg negative, Anti HBc positive, Ab anti HBs positive or negative, during a laboratory assay on serum
- Group 4: HBsAg positive, Anti HBc positive, Anti HBs negative, during a laboratory assay on serum
- all: affiliated to social security or beneficiary of such a scheme
Who cannot join
- Infection by a confounding factor: HIV, HCV and / or HDV
- Protected person: Pregnant woman, parturient, mother who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
- Exclusion period for other research studies involving the human person
- Annual threshold of allowances for participation in research involving the affected human person.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Validation of the Demonstrator of an In Vitro Diagnostic Device for Hepatitis B Screening
The principal objective of the study is to perform a first step of technical adjustment and preliminary validation of a diagnostic test for hepatitis B (HBsAntigen, anti-HBs Antibody and anti-HBc Antibody) on capillary blood with the device under study in non-immunized subjects against hepatitis B, in subjects with hepatitis B, in subjects with old or cured hepatitis B and in hepatitis B vaccine recipients, compared with the values obtained with the reference technique of medical biology laboratory on serum. The analysis will be performed on the entire cohort.
Read the detailed description
The diagnosis of hepatitis B in precarious populations is often difficult. The use of a in vitro diagnosis-medical device in point of care could alleviate this difficulty. It would identify whether or not the subjects are infected with the virus, whether they are immunized or not. Then, depending on the results, the subjects could be directly vaccinated or referred to a laboratory of medical biology for confirmation / invalidation of the diagnosis.
- Conditions
- Hepatitis B, Healthy, Diagnoses Disease
- Being tested
- Demonstrator MAGIA
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demonstrator MAGIADiagnostic test
Also called v0.1
test of capillary blood with the demonstrator at two time and 2 measures and 2 finger by subject.
| Study group | Role | What they receive |
|---|---|---|
| Non-immunized Hepatitis B | Experimental | subjects non-immunized against hepatitis B (naive) Receives: Diagnostic Test: Demonstrator MAGIA |
| Vaccine Hepatitis B | Experimental | subjects vaccinated against hepatitis B Receives: Diagnostic Test: Demonstrator MAGIA |
| Ongoing, Old or cured Hepatitis B | Experimental | subjects with hepatitis B (old or cured) Receives: Diagnostic Test: Demonstrator MAGIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of correlation
To evaluate the feasibility estimated by correlation of the measurements (HBsAg, anti-HBs Ab, HBc-Ab) between the IVD-MD in point of care on capillary blood study and the laboratory results obtained on serum
Measured: Day 0
Secondary outcomes (3)
repeatability of the measurement HBsAg, anti-HBs Ab, HBc-Ab
Comparison of the repeatability of the measurement of HBsAg, anti-HBs Ab, HBc-Ab on 2 different fingers with the same device and the same batch of consumables with 2 different times
Measured: day 0
reproductibility of the measurement HBsAg, anti-HBs Ab, HBc-Ab
Comparison of the reproducibility of HBsAg, anti-HBs Ab, HBc-Ab via a test from 2 drops of blood on 2 different fingers with 2 different cartridges and two different readers
Measured: day 0
correlation according to status
Comparison of the correlation coefficients of the measurements between the IVD-MD in point of care and the biology automaton according to the different statuses
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start21 Oct 2019
- Primary completion13 May 2022
- Study completion13 May 2022
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.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 3 parallel groups of 10 volunteers
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- MagIA Diagnostics
- Responsible party
- Sponsor
- Investigators
- Jean-Luc CRACOWSKI, MD, PhD, Principal investigator, Grenoble Alps University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109625
- Sponsor's protocol ID
- 38RC.19.159
- Acronym
- DiVHeB
- Status last verified
- May 2022
- First submitted
- 20 Sep 2019
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Validation of the Demonstrator of an In Vitro Diagnostic Device for Hepatitis B Screening
- ClinicalTrials.gov ID
- NCT04109625
- Acronym / sponsor ID
- DiVHeB / 38RC.19.159
- Conditions
- Hepatitis B, Healthy, Diagnoses Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- MagIA Diagnostics
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 13 May 2022 (actual)
- First posted
- 30 Sep 2019 (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.
The principal objective of the study is to perform a first step of technical adjustment and preliminary validation of a diagnostic test for hepatitis B (HBsAntigen, anti-HBs Antibody and anti-HBc Antibody) on capillary blood with the device under study in non-immunized subjects against hepatitis B, in subjects with hepatitis B, in subjects with old or cured hepatitis B and in hepatitis B vaccine recipients, compared with the values obtained with the reference technique of medical biology laboratory on serum. The analysis will be performed on the entire cohort.
Detailed description
The diagnosis of hepatitis B in precarious populations is often difficult. The use of a in vitro diagnosis-medical device in point of care could alleviate this difficulty. It would identify whether or not the subjects are infected with the virus, whether they are immunized or not. Then, depending on the results, the subjects could be directly vaccinated or referred to a laboratory of medical biology for confirmation / invalidation of the diagnosis.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 parallel groups of 10 volunteers
| Arm | Type | Receives |
|---|---|---|
| Non-immunized Hepatitis B | Experimental | Diagnostic Test: Demonstrator MAGIAsubjects non-immunized against hepatitis B (naive) |
| Vaccine Hepatitis B | Experimental | Diagnostic Test: Demonstrator MAGIAsubjects vaccinated against hepatitis B |
| Ongoing, Old or cured Hepatitis B | Experimental | Diagnostic Test: Demonstrator MAGIAsubjects with hepatitis B (old or cured) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Group 1: HBsAg negative, Anti HBc negative, Anti HBs negative, during a laboratory assay on serum
- Group 2: HBsAg negative, Anti HBc negative, Anti HBs positive, during a laboratory assay on serum
- Group 3: HBsAg negative, Anti HBc positive, Ab anti HBs positive or negative, during a laboratory assay on serum
- Group 4: HBsAg positive, Anti HBc positive, Anti HBs negative, during a laboratory assay on serum
- all: affiliated to social security or beneficiary of such a scheme
Key exclusion criteria (4 listed)
- Infection by a confounding factor: HIV, HCV and / or HDV
- Protected person: Pregnant woman, parturient, mother who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
- Exclusion period for other research studies involving the human person
- Annual threshold of allowances for participation in research involving the affected human person.
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 |
|---|---|---|
| Demonstrator MAGIAAlso: v0.1test of capillary blood with the demonstrator at two time and 2 measures and 2 finger by subject. | Diagnostic test | Non-immunized Hepatitis B, Ongoing, Old or cured Hepatitis B, Vaccine Hepatitis B |
Primary outcome
feasibility of correlation
Time frame: Day 0
To evaluate the feasibility estimated by correlation of the measurements (HBsAg, anti-HBs Ab, HBc-Ab) between the IVD-MD in point of care on capillary blood study and the laboratory results obtained on serum
3 secondary outcomes
repeatability of the measurement HBsAg, anti-HBs Ab, HBc-Ab
Time frame: day 0
reproductibility of the measurement HBsAg, anti-HBs Ab, HBc-Ab
Time frame: day 0
correlation according to status
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Hepatitis B
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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.
Jean-Luc CRACOWSKI, MD, PhD principal investigator
Grenoble Alps University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Demonstrator MAGIA in people with Hepatitis B and Healthy, run by University Hospital, Grenoble at 1 site in France.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 24 May 2022. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
feasibility of correlation (time frame: Day 0). 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 24 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.