Expanded Access Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Liver Injury in Children

NCT ID: NCT02925520


Title
Expanded Access Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Liver Injury in Children
Purpose
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.
Details
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.
Conditions
Parenteral Nutrition-Associated Liver Disease
Keywords
Cholestasis
Source
Cook Children's Health Care System
Sponsors
Cook Children's Health Care System
Status
Available
Acronym
Last Updated
03 Oct 2016
URL
Official Link
Citations/Publications
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Locations
United States