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 @ 4:50 AM
Ignite Modification Date:
2025-12-25 @ 4:50 AM
NCT ID:
NCT02246218
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects up to 2 years of age
* Signed informed consent by subject's parent/legal guardian
* UCD diagnosis or suspected diagnosis of any subtype, except N-acetyl glutamate synthetase deficiency. If UCD has not been previously confirmed by genetic testing, consent must be obtained from parent/legal guardian prior to perform genetic testing. If genetic testing is inconsistent with or excludes a UCD diagnosis, the subject will be withdrawn from the study.
Exclusion Criteria:
* Use of any investigational drug within 30 days of Day 1
* Uncontrolled infection (viral or bacterial) or any other condition known to precipitate hyperammonemic crises. Once these precipitating factors are medically controlled, patients presenting in crisis are eligible.
* Any clinical or laboratory abnormality of Grade 3 or greater severity according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03, except Grade 3 elevations in ammonia and liver enzymes, defined as levels 5-20 times the upper limit of normal in alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma glutamyl transpeptidase (GGT) in a clinically stable subject
* Any clinical or laboratory abnormality or medical condition that, at the discretion of the Investigator, may put the subject at increased risk by participating in this study
* Known hypersensitivity to phenylacetate (PAA) or phenylbutyrate (PBA)
* Liver transplantation, including hepatocellular transplant
* Subjects on hemodialysis at time of initiating RAVICTI
* Subjects on RAVICTI for UCD management
* Currently treated with Carbaglu® (carglumic acid)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
2 Years
Study:
NCT02246218
Study Brief:
Protocol Section:
NCT02246218