Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 3:23 AM
Study NCT ID:
NCT03481894
Status:
WITHDRAWN
Last Update Posted:
2019-09-04
First Post:
2015-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess Safety and Efficacy of Kabiven® in Pediatric Patients 2 to 16 Years of Age
Sponsor:
Fresenius Kabi
Organization:
Study Overview
Official Title:
Prospective, Randomized, Open-Label, Parallel-Group, Active-Controlled, Multicenter Study to Assess Safe and Effective Doses of Kabiven® in Pediatric Patients 2 to 16 Years of Age
Status:
WITHDRAWN
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
FDA released Fresenius Kabi from this post marketing requirement on 07/16/2019.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Demonstrate the safety and efficacy of Kabiven compared to standard parenteral nutrition (PN) administered via central vein in pediatric patients (2 to 16 years of age) requiring PN to meet nutritional needs.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: