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 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT01016392
Eligibility Criteria:
Inclusion Criteria:
* Adult or pediatric subject (no age limit) of either gender with HPA due to PKU or BH4 deficiency.
* Have been shown to be responsive to BH4 or Kuvan. (Note: For Spain only-Have been shown to be responsive to BH4 or for the newly diagnosed subjects to be responsive to Kuvan as defined in the Summary of Product Characteristics \[SmPC\]).
* Currently being treated with Kuvan® at a participating centre.
* Subject or parent/legal guardian willing and able to provide written signed informed consent and given before any data collection. If a child is old enough to read and write, a separate assent form will be given.
Exclusion Criteria:
* Known hypersensitivity to Kuvan®
* Legal incapacity or limited legal capacity without legal guardian representation
* Breast-feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Study:
NCT01016392
Study Brief:
Protocol Section:
NCT01016392