Status:
COMPLETED
Preliminary Validation of an in Vitro Diagnosis-medical Device for Hepatitis B Screening
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
MagIA Diagnostics
Conditions:
Hepatitis B
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 Anti...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04109625
Start Date
October 21 2019
End Date
May 13 2022
Last Update
May 24 2022
Active Locations (1)
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1
Clinical research center CIC1406
Grenoble, France, 38000