NCT05998109

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

December 15, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

8 months

First QC Date

August 10, 2023

Last Update Submit

September 8, 2025

Conditions

Phenylketonurias

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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

HPLC Amino Acid AnalyzerDIAGNOSTIC_TEST

1 venous specimen collected at each study visit

Dried Blood Spot CardsDIAGNOSTIC_TEST

capillary blood specimen collected at each study visit

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients ≥ 10 years who are undergoing monitoring for Phenylketonuria (PKU)

You may qualify if:

  • years of age or older
  • Being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy Signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Phenylketonurias

Condition Hierarchy (Ancestors)

Brain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2023

First Posted

August 18, 2023

Study Start

December 15, 2023

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

September 15, 2025

Record last verified: 2025-09

Locations

US(1)