Evaluation of Capillary Blood Collection Devices (Mitra® and HemaPEN®)

Last updated: December 18, 2023
Sponsor: University Hospital, Grenoble
Overall Status: Active - Recruiting

Phase

N/A

Condition

Phenylketonuria

Metabolic Disorders

Treatment

DM-DIV MITRA®

Clinical Study ID

NCT05894122
38RC22.0319
2023-A01180-45
  • Ages 3-18
  • All Genders

Study Summary

The aim is to demonstrate a new application for a blood collection device. This device is already widely used in pharmacology. It is not currently used for metabolic diseases.

Its ease of use enables repeated sampling at home. What's more, the device can be sent by post, making it ideally suited to the needs of this cohort of children, whose phenylalanine levels need to be monitored very regularly.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children aged 3 months to 18 years
  • suffering from phenylketonuria or hyperphenylalaninemia
  • who have had a capillary and blood test including a phenylalanine assay at CHUGA
  • Whose parents or legal guardians are affiliated to the social security system.
  • For whom parents or legal guardians have not objected to the MitrAlanine study.

Exclusion

Exclusion Criteria:

  • Parents or legal guardians opposed to the MitrAlanine study

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: DM-DIV MITRA®
Phase:
Study Start date:
December 13, 2023
Estimated Completion Date:
December 12, 2025

Connect with a study center

  • CHU Grenoble Alpes

    Grenoble, 38043
    France

    Active - Recruiting

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