EICHORCondition: Hepatitis B · Sponsor: CerbaXpert
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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 CRO of the Cerba Healthcare group promoted this performance study by setting up a prospective collection of blood samples from patients with hepatitis B virus and whose viral load is positive. This prospective collection will be carried out in 3 laboratories of the Cerba Healthcare group.
This description comes directly from the study's public registry record.
Sabrina KALI, Dr. · 33762376831 · kali.rinasab@gmail.com
There is no obligation to join — the study team can answer your questions about taking part.
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Inclusion Criteria: 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 Criteria: Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial decision or administrative • Subject participating in another clinical study
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Cerba Xpert | Frépillon, Ile de Franace, France | Not Yet Recruiting |
| Cerballiance Chemin vert | France, Paris, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06623071