Status:
RECRUITING
Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384
Lead Sponsor:
CerbaXpert
Collaborating Sponsors:
Bioneer Corporation
Conditions:
Hepatitis B
Eligibility:
All Genders
18+ years
Brief Summary
As part of the CE marking of a hepatitis B diagnostic kit, the South Korean manufacturer Bioneer wishes to set up a performance study in France in accordance with the IVDR (RE 2017/746). Cerba Xpert ...
Detailed Description
Viral hepatitis are primarily human systemic infections caused by viruses hepatic diseases which cause damage to the liver by hepatocyte infection of the virus and/or a host immune response to the vir...
Eligibility Criteria
Inclusion
- The patient to be included in this study must be able to understand the purpose research, in order to give free and informed consent.
- Subject aged over 18
- Subject presenting himself at the investigation center and responding to one of these two criteria:
- Subject presenting with a prescription for determination HBV viral load
- Subject with previously confirmed HBV infection by CE marked tests.
- Subject capable of understanding the aim of the research having given express free and informed consent
- Subject affiliated to or beneficiary of a social security system
Exclusion
- Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial decision or administrative
- • Subject participating in another clinical study
Key Trial Info
Start Date :
October 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06623071
Start Date
October 1 2024
End Date
May 31 2025
Last Update
March 26 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Cerba Xpert
Frépillon, Ile de Franace, France, 95000
2
Cerballiance Chemin vert
France, Paris, France, 75000