Ignite Creation Date:
2024-05-06 @ 3:15 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02246218
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2014-09-17
Brief Title:
A Study of the Safety Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate in Pediatric Subjects Under 2 Years of Age With Urea Cycle Disorders
Sponsor:
Organization:
Amgen
Study Design
Study Type:
INTERVENTIONAL
Expanded Access Type Individual:
None
Expanded Access Type Intermediate:
None
Expanded Access Type Treatment:
None
Patient Registry:
None
Target Duration:
None
Design Allocation:
Design Intervention Model:
Design Intervention Model Description:
Design Masking Description:
Bio Spec Retention:
None
Bio Spec Description:
None
Enrollment Count:
27
Enrollment Type:
ACTUAL
Design Primary Purpose:
Design Masking:
Phases:
| Name |
|---|
| PHASE4 |
Observational Models:
Time Perspective List:
Who Masked List: