Recruiting

Observational Study

Sponsor:

Aptatek BioSciences, Inc

Code:

NCT07551921

Conditions

Phenylketonuria (PKU) and Hyperphenylalaninemia

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Interventions

PheCheck

Dried Blood Spot Cards.

Study Details

Brief summary:

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).

Conditions

Phenylketonuria (PKU) and Hyperphenylalaninemia

Study ID

NCT07551921

Start date

Aug 20, 2026

Status verified date

Aug, 2026

Completion date

Apr 20, 2027

Anticipated

Primary completion date

Mar 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Previous enrollment in the study and has completed 3 study visits
  • Inability to read and understand instructions

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with Phenylketonuria or Hyperphenylalaninemia

Device: PheCheck Test Description: Quantitative, single-use, rapid test Intended for home-based self-testing and monitoring of PKU. 1 fingerstick specimen collected at each study visit Comparator: Dried Blood Spot Cards. 1 fingerstick specimen collected at each study visit

Interventions

PheCheck

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.

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

Primary outcome measure

  • Performance of the PheCheck™ test for the detection of phenylalanine (Phe) concentration from capillary blood as compared to the reference method (DBS) [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Catalina Suarez-Cuervo, MD

727-776-5880Clinicalstudies@lumosdiagnostics.com

Locations

Lurie Children's Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Steven J Eichinger

(312) 227-8952seichinger@luriechildrens.org

Principal Investigator:

Erika Vucko

More Information

Sponsor

Aptatek BioSciences, Inc

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • Phenylketonuria
  • PKU
  • Hyperphenylalaninemia
  • Phenylalanine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Aptatek BioSciences, Inc on 2026-08-25.