Compassionate Use of Omegaven IV Fat Emulsion

Cindy Haller

Status and phase

Terminated

Phase 2

Conditions

Total Parenteral Nutrition-induced Cholestasis

Cholestasis

Treatments

Drug: Omegaven

Study type

Interventional

Funder types

Other

Identifiers

NCT00816348

08-204

Details and patient eligibility

About

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).

Full description

Intravenous lipids are necessary in PN (parenteral nutrition) dependent patients due to their high caloric value and essential fatty acid content. However, parenteral fat emulsions composed of soybean oils (omega 6 fatty acids) have been implicated in predisposing patients to PN associated liver disease.

It is hypothesized that by administering Omegaven®, comprised of fish oil (omega 3 fatty acids) in place of conventional soybean fat emulsion, the progression of PN-associated cholestasis may be prevented or reversed.

Enrollment

15 patients

Sex

All

Ages

2 weeks to 5 years old

Volunteers

No Healthy Volunteers

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).