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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT01806051
Eligibility Criteria:
Inclusion Criteria:
PKU PARTICIPANTS (ARM 1):
* Subject has a confirmed diagnosis of PKU with hyperphenylalaninemia documented by a fasting Phenylalanine level of at least 360 umol/L (6 mg/dL)
* Patient is at least 4 years old (there is no upper age limit for this study)
* Willing and able to provide written authorization or, if under the age of 18 years, provide written assent (if required) and written patient authorization by a parent or legal guardian
* Willing to undergo study related procedures including commencing Kuvan treatment for patient not currently on treatment; temporary discontinuation of Kuvan for patient on treatment; and completing the 24-Hour Blood Assessment
* Authorized to provide personal health information
* Subjects should not be pregnant and willing to use appropriate birth control during the study
CONTROL GROUP (ARM 2):
* Healthy, non-PKU individuals. They will be age-sex matched to the PKU group. They may be a relative (ex: sibling) of a PKU participant, but they don't have to be a blood relation.
* Individual is at least 4 years old (there is no upper age limit)
* Willing and able to provide written consent or, if under the age of 18 years, provide written assent and written participant authorization by a parent or legal guardian
* Authorized to provide personal health information
Exclusion Criteria (BOTH ARMS):
* Subjects who do not meet all the inclusion criteria
* Age \< 4 years
* Concomitant medical problems or medications which at the discretion of the principal investigator would put participant at health risk or prevent them from completing study.
* If female, unwillingness to use birth control during the period of the study drug administration (this doesn't apply to Arm 2)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Study:
NCT01806051
Study Brief:
Protocol Section:
NCT01806051