Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2026-01-28 @ 4:08 PM
Study NCT ID:
NCT02246218
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2014-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
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:
Amgen
Organization:
Key Dates - Follows AllAPIJSON File Order
Start Date:
2014-12-31
Start Date Type:
ACTUAL
Primary Completion Date:
2016-10-17
Primary Completion Date Type:
ACTUAL
Completion Date:
2017-07-17
Completion Date Type:
ACTUAL
First Submit Date:
2014-09-17
First Submit QC Date:
None
Study First Post Date:
2014-09-22
Study First Post Date Type:
ESTIMATED
Results First Submit Date:
2019-01-14
Results First Submit QC Date:
None
Results First Post Date:
2019-03-05
Results First Post Date Type:
ACTUAL
Results First Post QC Date:
None
Results First Post QC Date Type:
None
Disp First Submit Date:
None
Disp First Submit QC Date:
None
Disp First Post Date:
2017-10-18
Disp First Post Date Type:
ACTUAL
Last Update Submit Date:
2024-06-18
Last Update Post Date:
2024-07-01
Last Update Post Date Type:
ACTUAL