Compassionate Use of Omegaven IV Fat Emulsion

• Status: Terminated
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cindy Haller

Criteria

Inclusion Criteria:

• 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®).

Exclusion Criteria:

• 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).