Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-30 @ 5:35 PM
Study NCT ID:
NCT01425567
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2019-02-12
First Post:
2011-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compassionate Use of IV Fish Oil for Parenteral Nutrition (PN) Liver Injury
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
Study Overview
Official Title:
Compassionate Use of an Intravenous Lipid Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Children
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2019-01
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:
Omegaven
Brief Summary:
To establish a process by which critically ill infants with parenteral nutrition-associated liver disease can receive a fish oil-based intravenous lipid emulsion (Omegaven®) for compassionate use when no satisfactory alternative treatments are available.
Detailed Description:
Patients who meet the inclusion criteria (having a direct bilirubin ≥4.0 mg/dL) and are consented will be discontinued from standard soybean-based lipid emulsion and started on Omegaven®. Omegaven® will be infused continuously via either a peripheral or central catheter at a dose of 1 gm/kg/day along with parenteral nutrition (PN).
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?: