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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT05249218
Eligibility Criteria:
Inclusion Criteria:
* PKU patients diagnosed by NBS and BH4 deficiencies;
* Early and continuously treated;
* Adherent to their prescribed PKU diet consisting of a protein-restricted diet and Phe-free amino acid based protein substitute;
* In good general health as evidenced by medical history;
* Able to provide written informed consent/assent (parent/child);
* Able to comply with the study protocol and take study product according to the opinion of the PI;
* Patients with good metabolic control (age 5-12y, 120-360μmol/L) with 3 out of 4 levels within range prior to consent (if 2 of 4 above target range but one close to the upper limit, PI to decide if patient can enter the study).
Exclusion Criteria:
* Concomitant diseases / disorders such as renal or gut disease / disorders and diabetes;
* Dislikes fruits and vegetables containing 76-100 mg of Phe/100g e.g.brocolli or cauliflower;
* Treated with BH4 (sapropterin);
* Presence of intercurrent infection;
* Patients with poor metabolic control (age 5-12y, \>360μmol/L).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
12 Years
Study:
NCT05249218
Study Brief:
Protocol Section:
NCT05249218