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Clinical Trials/DRKS00031972
DRKS00031972
Not yet recruiting
Not Applicable

Study to evaluate the reliability and practicability of the PKU Sensor and PKU App in home settings of patients with phenylketonuria - PKU Sensor

niversity Hospital Heidelberg0 sites50 target enrollmentJune 5, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
E70.0
Sponsor
niversity Hospital Heidelberg
Enrollment
50
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 5, 2023
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
niversity Hospital Heidelberg

Eligibility Criteria

Inclusion Criteria

  • Genetically confirmed phenylalanine hydroxylase deficiency
  • Patients or their parents are capable to give informed consent (written informed consent, signed and dated)
  • Willing and able to comply with the protocol and study procedures
  • Male/ female/diverse patients
  • Newborns (after birth until the end of the 4th week of life
  • Toddlers (5th week of life to the end of the 1st year of life)
  • Infants (1st to the end of the 5th year of life)
  • Children (6th to the end of the 11th year)
  • Adolescents (from the age of 12 to the end of 17\)
  • Adults (18\-99 years)

Exclusion Criteria

  • The individual, in the opinion of the investigator, is unwilling or unable to adhere to the requirements of the study
  • Any other know genetic disorder in amino acid metabolism
  • Participation in interventional clinical studies
  • Mentally disabled persons that are needing a legal representative

Outcomes

Primary Outcomes

Not specified

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