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PheCheck™ Validation Study

Recruitingn/aAges 1 Year - anyAllAptatek BioSciences, Inc
NCT07551921 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to evaluate the performance of the PheCheck™ test for the rapid detection of phenylalanine (Phe) from a fingerstick sample, in patients 1 year or older with phenylketonuria (PKU) or hyperphenylalaninemia. The main objective is comparing the concentration of phenylalanine (Phe) in capillary blood with the reference method (DBS).

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📋 Eligibility rules (as published)
Inclusion Criteria: * 1 year or older and able to have a fingerstick blood collected * Being monitored for Phenylketonuria (classical PKU, mild PKU, variant PKU, or hyperphenylalaninemia) * Signed informed consent Exclusion Criteria: * Previous enrollment in the study and has completed 3 study visits * Inability to read and understand instructions
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What it tests

  • PheCheck
  • Dried Blood Spot Cards.
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Where

2 sites
Lurie Children's Hospital
Chicago, United States
Boston Children's Hospital
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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