Preliminary Validation of an in Vitro Diagnosis-medical Device for Hepatitis B Screening

NCT04109625 | Completed

• 1 other identifier: 38RC.19.159
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hepatitis B; Healthy; Diagnoses Disease

Outcome Measures

Primary Outcomes (1)

• 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

  Day 0

Secondary Outcomes (3)

• repeatability of the measurement HBsAg, anti-HBs Ab, HBc-Ab

  day 0

• reproductibility of the measurement HBsAg, anti-HBs Ab, HBc-Ab

  day 0

• correlation according to status

  day 0

Study Arms (3)

Non-immunized Hepatitis B

EXPERIMENTAL

subjects non-immunized against hepatitis B (naive)

Diagnostic Test: Demonstrator MAGIA

Vaccine Hepatitis B

EXPERIMENTAL

subjects vaccinated against hepatitis B

Diagnostic Test: Demonstrator MAGIA

Ongoing, Old or cured Hepatitis B

EXPERIMENTAL

subjects with hepatitis B (old or cured)

Diagnostic Test: Demonstrator MAGIA

Interventions

Demonstrator MAGIA DIAGNOSTIC_TEST

test of capillary blood with the demonstrator at two time and 2 measures and 2 finger by subject.

Also known as: v0.1

Non-immunized Hepatitis B; Ongoing, Old or cured Hepatitis B; Vaccine Hepatitis B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Annual threshold of allowances for participation in research involving the affected human person.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• MagIA Diagnostics: collaborator

Study Sites (1)

Clinical research center CIC1406

Grenoble, 38000, France

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Jean-Luc CRACOWSKI, MD, PhD

  Grenoble Alps University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 parallel groups of 10 volunteers

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 30, 2019
• Study Start: October 21, 2019
• Primary Completion: May 13, 2022
• Study Completion: May 13, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

FR (1)