Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-02-19 @ 5:52 AM
Study NCT ID:
NCT02929303
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2025-10-01
First Post:
2016-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access of Omegaven IV Fat Emulsion to Infants and Children With PNALD
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Expanded Access of Omegaven IV Fat Emulsion (Fish Oil Infusion) to Infants and Children With Parenteral Nutrition-associated Liver Disease
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2025-09
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 an expanded access protocol for use of intravenous fish oil infusion, Omegaven, in infants and children with parenteral nutrition associated liver disease (PNALD) to decrease elevated liver enzymes and direct bilirubin.
This study aims to describe the response of PNALD after use of Omegaven by normalization of serum levels of liver enzymes and bilirubin.
This study aims to describe the response of PNALD after use of Omegaven by normalization of serum levels of liver enzymes and bilirubin.
Detailed Description:
The etiology of parenteral nutrition associated liver disease (PNALD) is currently considered multifactorial. Available treatment options for this disease process are limited and have achieved moderate success at best. Unlike conventional intravenous fat emulsions, Omegaven™ is comprised solely of fish oils containing primarily omega-3 fatty acids. The investigators hypothesize that administering Omegaven™ to patients with PNALD in place of conventional fat emulsion may reverse cholestasis allowing patients to be maintained on adequate PN until they are able to ingest adequate nutrition enterally.
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?: