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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT03409003
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of NAGS deficiency or suspicion of NAGS deficiency
* Carbaglu intake for the treatment of NAGS
* Enrolled in the Longitudinal Study of Urea Cycle Disorders (RDCRN protocol #5101)
Exclusion Criteria:
* Cases of hyperammonemia caused by other urea cycle disorders
* Organic acidemia, lysinuric protein intolerance
* Mitochondrial disorders
* Congenital lactic acidemia,
* Fatty acid oxidation defects
* Primary liver disease will be excluded
* Individuals with extreme low birth weight (\<1,500 grams) will be also excluded.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03409003
Study Brief:
Protocol Section:
NCT03409003