Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2023-12-15
2024-07-31
Brief Summary
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The main aims are:
* Evaluate the accuracy of PheCheck as compared to the gold standard
* Evaluate ease of use by lay participants
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Detailed Description
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The study will enroll subjects into one study cohort. It will include patients 10 years or older, monitored for Phenylketonuria (PKU), hyperphenylalaninemia or PKU during pregnancy.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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PheCheck™
Quantitative, single-use, rapid test Intended for home-based self-testing and monitoring of PKU.
1 fingerstick specimen collected at each study visit
HPLC Amino Acid Analyzer
1 venous specimen collected at each study visit
Dried Blood Spot Cards
capillary blood specimen collected at each study visit
Eligibility Criteria
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Inclusion Criteria
* Being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy Signed informed consent
Exclusion Criteria
* Not being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy
* Lack of signed informed consent
* Previous enrollment in the study and has completed study visit 1 and 2
10 Years
ALL
No
Sponsors
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Aptatek Biosciences
UNKNOWN
Lumos Diagnostics
INDUSTRY
Responsible Party
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Locations
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UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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CLP-0012
Identifier Type: -
Identifier Source: org_study_id
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