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Recruiting No phase listed Observational

PheCheck™ Validation Study

ClinicalTrials.gov ID: NCT07551921

Public ClinicalTrials.gov record NCT07551921. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 5:40 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT07551921
Recruitment status
Recruiting
Study type
Observational
Phase
Not listed
Lead sponsor
Aptatek BioSciences, Inc
Industry
Enrollment
60 participants

Conditions and interventions

Interventions

Device · Diagnostic Test

Eligibility (public fields only)

Age range
1 Year and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 19, 2026
Primary completion
Mar 19, 2027
Completion
Apr 19, 2027
Last update posted
Aug 24, 2026

2026 – 2027

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Lurie Children's Hospital Chicago Illinois 60611 Recruiting
Boston Children's Hospital Boston Massachusetts 02115 Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07551921, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 24, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07551921 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →