Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT06940193
Eligibility Criteria:
Inclusion Criteria:
* All individuals with PKU aged 3 years and over
* Subjects with a confirmed diagnosis of PKU detected from newborn screening
* Healthy adult volunteers (\>18 years of age) without PKU
* Male and female subjects will be included in this study.
Exclusion Criteria:
* Children under the age of 3 years
* Individuals with needle phobia
* Patients with comorbidities that may affect tolerance of blood sampling e.g. autism or other neurodiversity disorders
* Patients with acute illness e.g. chicken pox, tonsillitis requiring antibiotics
* Patients with chronic illness and taking long term medications e.g. diabetes.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
3 Years
Study:
NCT06940193
Study Brief:
Protocol Section:
NCT06940193