NCT06623071 Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384
| NCT ID | NCT06623071 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CerbaXpert |
| Condition | Hepatitis B |
| Study Type | OBSERVATIONAL |
| Enrollment | 45 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2025-03-24 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 45 participants in total. It began in 2024-10-01 with a primary completion date of 2025-03-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06623071 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatitis B. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06623071 currently recruiting?
Yes, NCT06623071 is actively recruiting participants. Contact the research team at kali.rinasab@gmail.com for enrollment information.
Where is the NCT06623071 trial being conducted?
This trial is being conducted at Frépillon, France, France, France.
Who is sponsoring the NCT06623071 clinical trial?
NCT06623071 is sponsored by CerbaXpert. The trial plans to enroll 45 participants.