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NCT05998109 Clinical Trial

PheCheck Feasibility Study

Phenylketonurias Clinical Trial

Official title:
PheCheck Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data
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

Study information
Verified date January 2024
Source Lumos Diagnostics
Contact Catalina Suarez-Cuervo, MD
Phone 7277765880
Email Catalina.Suarez@lumosdiagnostics.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

The primary objective of this feasibility study is to evaluate the accuracy of the analyte concentration of PheCheck™ for the rapid, quantitative detection of phenylalanine (Phe) from capillary blood compared to the gold standard (HPLC amino acid analyzer) which quantitatively measures Phe in venous blood. 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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• PheCheck™
Quantitative, single-use, rapid test Intended for home-based self-testing and monitoring of PKU. 1 fingerstick specimen collected at each study visit
Diagnostic Test:
• HPLC Amino Acid Analyzer
1 venous specimen collected at each study visit
• Dried Blood Spot Cards
capillary blood specimen collected at each study visit

Locations
Country Name City State
United States UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Lumos Diagnostics Aptatek Biosciences

Country where clinical trial is conducted

United States, 

Outcome
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
See also
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Terminated NCT05229549 - Study to Evaluate the Effect on Nitrogen Retention of Two Different Posology Schemes of PKU GOLIKE PLUS 3-16 and Free AAs in Patients With Phenylketonuria N/A
Enrolling by invitation NCT05356377 - Preliminary Study of Brain Effects of Palynziq-Related Changes in Phenylalanine in Individuals With PKU
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Completed NCT02445521 - Testing of Four Home Phenylalanine Monitoring Prototype Devices N/A