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:
Amgen
Organization:
Amgen
Study Overview
Official Title:
An Open Label Study of the Safety Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate GPB RAVICTI in Pediatric Subjects Under Two Years of Age With Urea Cycle Disorders UCDs
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label study consisting of a transition period to RAVICTI followed by a safety extension period for at least 6 months and up to 24 months of treatment with RAVICTI depending on age at enrollment It is designed to capture information important for evaluating safety pharmacokinetics and efficacy in young children
Subjects who are followed by or referred to the Investigator for management of their UCD Subjects eligible for this study will include patients ranging from newborn to 2 years of age with either a diagnosed or clinically suspected UCD
Subjects who are followed by or referred to the Investigator for management of their UCD Subjects eligible for this study will include patients ranging from newborn to 2 years of age with either a diagnosed or clinically suspected UCD
Detailed Description:
Study acquired from Horizon in 2024
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-003460-38 | EUDRACT_NUMBER | None | None |