Phenylketonurias Clinical Trial
Official title:
PheCheck Feasibility Study
NCT number | NCT05998109 |
Other study ID # | CLP-0012 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 5, 2023 |
Est. completion date | March 15, 2024 |
The goal of this feasibility study clinical trial is to compare the accuracy of PheCheck™ for the rapid quantitative detection of phenylalanine (Phe) with the gold standard (HPLC amino acid analyzer), in patients with PKU. The main aims are: - Evaluate the accuracy of PheCheck as compared to the gold standard - Evaluate ease of use by lay participants
Status | Recruiting |
Enrollment | 30 |
Est. completion date | March 15, 2024 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years and older |
Eligibility | Inclusion Criteria: - 10 years of age or older - Being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy Signed informed consent Exclusion Criteria: - Younger than 10 years of age - 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 |
Country | Name | City | State |
---|---|---|---|
United States | UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Lumos Diagnostics | Aptatek Biosciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concentration of phenylalanine (Phe) from PheCheck as compared to HPLC amino acid analyzer | The primary outcome is the concentration of phenylalanine (Phe) from capillary blood as compared to the gold standard HPLC amino acid analyzer | 6-8 weeks |
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