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:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-24 @ 9:55 PM
NCT ID:
NCT06941532
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* Over 3 years of age
* Patients diagnosed with any phenotype of PKU characterised by hyperphenylalaninaemia or patients diagnosed with tyrosinaemia
* Have been compliant in taking at least one protein substitute, providing at least 15g protein equivalents, for at least 1 month prior to trial commencement
* Have a prescribed daily phenylalanine or phenylalanine and tyrosine allowance for PKU or TYR respectively
* Written or electronic informed consent from patient, and/or from parent/caregiver if applicable
* Participants who are anticipated to be able to take at least one sachet of GMP Product per day
Exclusion Criteria:
* Pregnant or lactating
* Requiring parenteral nutrition
* Major hepatic or renal dysfunction
* Participation in other studies within 1 month prior to entry of this study
* Allergy to any of the study product ingredients
* Investigator concern around willingness/ability of patient or parent/caregiver to comply with protocol requirement
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Study:
NCT06941532
Study Brief:
Protocol Section:
NCT06941532