Expanded Access of Omegaven IV Fat Emulsion to Infants and Children With PNALD
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|ClinicalTrials.gov Identifier: NCT02929303|
Expanded Access Status : Available
First Posted : October 11, 2016
Last Update Posted : February 19, 2018
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.
|Condition or disease||Intervention/treatment|
|Total Parenteral Nutrition-induced Cholestasis||Drug: Omegaven IV lipid emulsion|
|Study Type :||Expanded Access|
|Official Title:||Expanded Access of Omegaven IV Fat Emulsion (Fish Oil Infusion) to Infants and Children With Parenteral Nutrition-associated Liver Disease|
- Drug: Omegaven IV lipid emulsion
Therapy is started at a dose of 1 gm/kg/day over 12 hrs. Omegaven may be infused via a central or peripheral IV. If additional fat calories are needed they will be provided by the enteral route.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929303
|Contact: Hector Hernandez, MD||(847) 723-7700||Hector.firstname.lastname@example.org|
|Contact: Paul Kasprzak, Rph, BCPS||(708) email@example.com|
|United States, Illinois|
|Advocate Children's Hospital|
|Park Ridge, Illinois, United States, 60068|
|Contact: Kelly Kopec, PharmD 847-723-8370 firstname.lastname@example.org|
|Contact: Paul Kasprzak, Rph, BCPS (708) 684-5749 email@example.com|
|Principal Investigator: Hector Hernandez, MD|
|Sub-Investigator: Paul Kasprzak, Rph, BCPS|
|Sub-Investigator: Kelly Kopec, PharmD|