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 @ 4:43 AM
Ignite Modification Date:
2025-12-25 @ 4:43 AM
NCT ID:
NCT00244218
Eligibility Criteria:
Inclusion Criteria:
* Subject and/or parent or guardian must be capable of understanding and providing written informed consent
* Subjects must have Phenylketonuria (PKU)or hyperphenylalaninemia (HPA), defined as baseline blood Phe levels of \>600 umol/L
* Subjects must be at least 10 years of age, and may be of either gender and any ethnic group
* Female subjects of childbearing potential must agree to use adequate birth control or refrain from sexual activity throughout study participation
Exclusion Criteria:
* Female subjects who are pregnant or breastfeeding
* Subjects who have concurrent diseases or conditions that require medication or treatment
* Subjects who require concomitant treatment with any drug known to inhibit folate synthesis
* Subjects who have been treated with any investigational drug within 30 days
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT00244218
Study Brief:
Protocol Section:
NCT00244218