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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT04679467
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with PKU or hyperphenylalaninemia via new born screening and early treated, requiring \>50% of protein intake from protein substitute.
* Aged 3 years and above.
* Female patients of childbearing potential must have a negative urine pregnancy test prior to completing the screening procedures.
* Willingly given, written, informed consent from the participant, 18 or more years, or from the parent/guardian for participants \< 18 years.
* Willingly given, written assent (if appropriate) for those \< 18 years.
Exclusion Criteria:
* Pregnant, planning pregnancy or breastfeeding.
* Intake of sapropterin dihydrochloride (Kuvan), PEG PAL or large neutral amino acids within 30 days prior to screening visit.
* Patients currently taking their maximum recommended amount of protein substitute from a GMP based protein substitute.
* Patients who are unable/unwilling to replace their current GMP protein substitute (if any) with PKU sphere.
* Patients with known soya, milk or fish allergies / intolerance.
* Individuals, who in the opinion of the investigator, are unable to comply with the requirements of the protocol.
* Any co-morbidity, which in the opinion of the Investigator, would preclude participation in the study.
* Patients who are currently participating in, plan to participate in, or have participated in an interventional investigational drug, food or medical device trial within 30 days prior to screening visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Study:
NCT04679467
Study Brief:
Protocol Section:
NCT04679467