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Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384

NCT06623071 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2025-03-26

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Bioneer Corporation

    collaborator UNKNOWN

  • CerbaXpert

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-03-24
Completion
2025-05-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06623071 on ClinicalTrials.gov