Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-09 @ 4:05 AM
Study NCT ID:
NCT01861834
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2019-05-07
First Post:
2013-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safer Parenteral Nutrition in Pediatric Short Bowel Syndrome to Decrease Liver Damage
Sponsor:
Georgetown University
Organization:
Study Overview
Official Title:
A Safer Approach to Total Parenteral Nutrition in Pediatric Short Bowel Syndrome Intended to Decrease the Frequency and Severity of Liver Damage
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To provide children dependent on total parenteral nutrition with Omegaven®, a fish oil-based intravenous lipid emulsion that may be less hepatotoxic than conventional, vegetable oil-based intravenous lipid emulsions, and that may therefore reduce the need for liver transplantation.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: