Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Associated Hepatic Injury
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|ClinicalTrials.gov Identifier: NCT01412359|
Expanded Access Status : Approved for marketing
First Posted : August 9, 2011
Last Update Posted : April 24, 2019
|Condition or disease||Intervention/treatment|
|Total Parenteral Nutrition-induced Cholestasis||Drug: Omegaven®|
In the United States, patients dependent upon parenteral nutrition (PN) receive parenteral fat emulsions composed of soybean oils. Lipids are necessary in PN dependent patients due to their high caloric value and essential fatty acid content. Phytosterols such as those contained in soybean oil based fat emulsions are thought to have a deleterious effect on biliary secretion and they have been implicated in predisposing patients to PN associated liver disease. Children requiring prolonged courses of PN are at risk for developing PN associated liver disease. The investigators hypothesize that although soybean oil based fat emulsions prevent fatty acid deficiency, they are not cleared in a manner similar to enteral chylomicrons and therefore accumulate in the liver resulting in steatotic liver injury.
Animal studies have shown that fish oil based IV fat emulsions(IFE)which are high in eicosapentaenic and docosahexaenoic acid, reduce impairment of bile flow seen in cholestasis caused by conventional fat emulsions. Omegaven® is a fish oil based IV fat emulsion. The investigators hypothesize that administering Omegaven® in place of conventional soybean fat emulsions may reverse or prevent the progression of PN associated cholestasis and thus allow the patient to be maintained on adequate PN until he/she is able to ingest adequate nutrition enterally.
Primary outcome measures to be addressed include the normalization of liver enzymes including bilirubin upon the start of Omegaven® and continued growth on Omegaven®. Safety measures will include the prevalence of essential fatty acid deficiency, hypertriglyceridemia, and bleeding disorders.
|Study Type :||Expanded Access|
|Expanded Access Type :||Treatment IND/Protocol|
|Official Title:||Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Associated Hepatic Injury|
- Drug: Omegaven®
Omegaven® 10% fat emulsion 1g/kg/day to infuse via IV over a period of 12 -24 hours every day until patient no longer requires intravenous lipid emulsion, is determined ineffective, or the patient stops participating in the study for any reason.Other Name: Intavenous fish oil emulsion
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): NCT01412359
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh of UPMC|
|Pittsburgh, Pennsylvania, United States, 15224|
|Principal Investigator:||Jeffrey A Rudolph, MD||University of Pittsburgh|