Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-27 @ 11:10 PM
Study NCT ID:
NCT02010034
Status:
COMPLETED
Last Update Posted:
2019-02-06
First Post:
2013-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition Induced Hepatic Injury
Sponsor:
Children's Medical Center Dallas
Organization:
Study Overview
Official Title:
Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition Induced Hepatic Injury
Status:
COMPLETED
Status Verified Date:
2019-02
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 study is being done to determine if an investigational study drug called Omegaven can help to improve liver disease thought to be caused by Total Parenteral Nutrition (TPN). TPN is intravenous feeding (IV feeding tube) that provides patients the nutrients when they are unable to drink fluid or eat food by mouth.
Detailed Description:
PAtients with direct bilirubin \>2gm/dL and short bowel syndrome are eligible for enrollment. Omegaven at 1gm/kg/day will be administered via central venous line instead of standard lipid preparations.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: