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NCT05894122 Clinical Trial

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

Metabolic Diseases Clinical Trial

— MitrAlanine  

Official title:
Evaluation of Capillary Blood Collection Devices (Mitra® and HemaPEN®) in the Context of Metabolic Diseases and, in Particular, Pediatric Monitoring of Phenylketonuria

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05894122
Other study ID # 38RC22.0319
Secondary ID 2023-A01180-45
Status Recruiting
Phase
First received
Last updated
Start date December 13, 2023
Est. completion date December 12, 2025

Study information
Verified date December 2023
Source University Hospital, Grenoble
Contact Christelle CORNE, MD
Phone 04 76 76 92 32
Email CCorne@chu-grenoble.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 12, 2025
Est. primary completion date December 12, 2025
Accepts healthy volunteers No
Gender All
Age group 3 Months to 18 Years
Eligibility 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 Criteria: - Parents or legal guardians opposed to the MitrAlanine study

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• DM-DIV MITRA®
Comparison of phenylalanine concentrations in the new device with those in the current device (blotter).

Locations
Country Name City State
France CHU Grenoble Alpes Grenoble

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of phenylalanine concentrations Comparison of phenylalanine concentrations in the new device with those in the current device (blotter). Day 1
Secondary Ease of use of research device ease of use of DM-DIV MITRA® and DM-DIV HemaPEN® via a 3 questions-and-answer guide for samplers Day 1
Secondary sample conformity Conformity of blood sample on DM-DIV MITRA® and DM-DIV HemaPEN® versus DM-DIV Perkin Elmer Day 1
Secondary comparison of concentrations of tyrosin comparison of concentrations of other amino acids (tyrosin) dosed at the same time as phenylalanine Day 1
Secondary comparison of concentrations of total leucin comparison of concentrations of other amino acids (total leucin) dosed at the same time as phenylalanine Day 1
Secondary comparison of concentrations of methionin comparison of concentrations of other amino acids (methionin) dosed at the same time as phenylalanine Day 1
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