Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-24 @ 6:04 PM
Study NCT ID:
NCT02370251
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2015-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Compassionate Use of Omegaven in Children
Sponsor:
University of Oklahoma
Organization:
Study Overview
Official Title:
Fish Oil Lipid Emulsion for the Treatment of Parenteral-Nutrition-Associated Liver Disease in Infants
Status:
COMPLETED
Status Verified Date:
2019-11
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 a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.
Detailed Description:
Children up to 18 years of age, on parenteral nutrition, with a direct bilirubin level of 2 mg/dL or greater will be eligible to receive Omegaven at a maximum dose of 1 g/kg/day.
Up to 200 children will be eligible for enrollment.
Direct bilirubin levels and other labs will be monitored as well as growth parameters.
Up to 200 children will be eligible for enrollment.
Direct bilirubin levels and other labs will be monitored as well as growth parameters.
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?: