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Clinical Trials/DRKS00024808
DRKS00024808
Completed
Not Applicable

Collection of blood samples for analytical performance evaluation under the IVDR of in vitro test systems in the area of Allergy and Nutrition Care - IVDR-All/NC-01

R-Biopharm AG0 sites26 target enrollmentAugust 27, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
AllergiesFood Intolerance
Sponsor
R-Biopharm AG
Enrollment
26
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 27, 2021
End Date
July 5, 2022
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. ability to understand and willingness to sign a written consent form.
  • 2\. females and males 18 years of age or older.
  • 3\. Presence of allergy(s) and/or food intolerance(s) (self\-reported).
  • 4\. collection of the required volume of whole blood and capillary blood possible.
  • 5\. min. 50 kg body weight (in case of allergy).

Exclusion Criteria

  • 6\. pregnant and lactating women
  • 8\. increased bleeding tendency, or known blood clotting disorder
  • 9\. intake of immunosuppressants
  • 10\. intake of Omalizumab
  • 11\. an event due to which, in the opinion of the principal investigator, the subject is not suitable for participation in the study.

Outcomes

Primary Outcomes

Not specified

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