PheCheck™ Validation Study

ConditionPhenylketonuria (PKU) and Hyperphenylalaninemia

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age1+

SponsorAptatek BioSciences, Inc

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Previous enrollment in the study and has completed 3 study visits

Inability to read and understand instructions

Trial population

Patients 1 year or older with phenylketonuria (PKU) or hyperphenylalaninemia

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

PheCheck
Device
Quantitative, single-use, rapid test Intended for home-based self-testing and monitoring of PKU. 1 fingerstick specimen collected at each study visit Sample read using an electronic reader. Results available within 1 hour
Dried Blood Spot Cards.
Diagnostic test
Laboratory-based reference method 1 fingerstick specimen at each study visit to collect 5 samples to fill 5 spots on the card. Card sent to a laboratory, results available within 72 hours

Treatment groups

60 Participants

are divided into 1 treatment group

Group A: Patients with Phenylketonuria or Hyperphenylalaninemia2 interventions

Trial outcomes

Primary outcomes

Performance of the PheCheck™ test for the detection of phenylalanine (Phe) concentration from capillary blood as compared to the reference method (DBS)

The primary objective of this study is to evaluate the performance of the PheCheck™ (Aptatek Biosciences) test for the rapid, quantitative detection of phenylalanine (Phe) direct from a capillary (fingerstick) sample. PheCheck™ is a self-test to be performed by PKU patients. Results will be compared to reference testing from Dried Blood Spot Cards (DBS) tested in a designated reference laboratory. Phe results will be blinded to the study participant

Time frame

Day 1

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aptatek BioSciences, Inc

Lead sponsor

Source ClinicalTrials.gov

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