Compassionate Use of Omegaven IV Fat Emulsion

Stopped early · Phase 2

Conditions studied: Cholestasis, Total Parenteral Nutrition-induced Cholestasis

In brief

This is a compassionate use protocol to use intravenous fish oil infusion, Omegaven®, to infants and children with parenteral nutrition-associated liver disease to enable reversal of elevated serum liver enzymes and direct bilirubin (cholestasis).

Key facts

Study ID

NCT00816348

Run by

Cindy Haller

People needed

15

Starts

2008-12-01

Expected to finish

2014-02-01

Last updated by the study team

2017-03-10

Who can join

Age: 0 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Two consecutive direct bilirubin levels of 2 mg/dl or more in a parenteral nutrition dependent infant or child (unable to meet nutritional needs solely by enteral nutrition)
• Other causes of liver disease have been excluded. A liver biopsy is not necessary for treatment.
• The patient must have utilized standard therapies to prevent the progression of the liver disease including reduction/removal of copper and manganese from daily PN, trial of enteral feeding if possible, and the use of ursodiol (i.e., Actigall®).

You may not qualify if…

• Documented causes of chronic liver disease other than parenteral nutrition associated liver disease
• Proven severe advanced liver disease including cirrhosis on biopsy, varices, ascites.
• An allergy to any seafood product, egg protein, and/or previous allergy to Omegaven®
• Active coagulopathy characterized by ongoing bleeding or by a requirement for clotting factor replacement (e.g. fresh frozen plasma or cryoprecipitate) to maintain homeostasis
• Impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis
• Unstable diabetes mellitus or hyperglycemia
• Stroke, embolism, collapse and shock, recent MI
• Cholestasis due to any reason other than parenteral associated liver disease
• Active new infection at time of initiation of Omegaven®
• Hemodynamic instability
• The patient may not be enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team).

Where it is running

• Cohen Children's Medical Cenetr of New York at North Shore — Manhasset, New York, United States
• Cohen Children's Medical Center of New York — New Hyde Park, New York, United States

Full record on ClinicalTrials.gov

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