Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT02925520
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2019-01-10
First Post:
2016-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expanded Access Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Liver Injury in Children
Sponsor:
Cook Children's Health Care System
Organization:
Study Overview
Official Title:
Expanded Access Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Liver Injury in Children
Status:
NO_LONGER_AVAILABLE
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:
None
Brief Summary:
This is an expanded access study to assess the safety profile and changes in serum direct bilirubin levels in infants with PN associated cholestasis. Eligible patients will receive therapy with Omegaven on an expanded access basis by method of continuous infusion. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. The same standards of care provided to all patients receiving parenteral nutrition solution will be followed.
Detailed Description:
This expanded access protocol provides a mechanism for critically ill infants with parenteral nutrition-associated liver disease (PNALD) to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.
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?: