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 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT06332105
Eligibility Criteria:
Inclusion Criteria:
* Patients with PKU, aged 5 to 16 years of age, currently compliant with protein restricted diet and L-AA- and/or GMP-AA-based protein substitute willing to switch to a GMP-AA-based only product for 4 weeks.
* 2 out of 4 last blood Phe levels within target range (i.e. 50%): Target range 120-360µmol/l \<12 years Target range 120-600µmol/l \>12 years
Exclusion Criteria:
* • Milk protein allergy
* Pregnancy
* Severe medical diagnosis not related to PKU
* Treatment with Sapropterin hydrochloride (KUVAN)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
16 Years
Study:
NCT06332105
Study Brief:
Protocol Section:
NCT06332105