Status:
TERMINATED
Compassionate Use of Omegaven IV Fat Emulsion
Lead Sponsor:
Cindy Haller
Conditions:
Cholestasis
Total Parenteral Nutrition-induced Cholestasis
Eligibility:
All Genders
2-5 years
Phase:
PHASE2
Brief 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 li...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00816348
Start Date
December 1 2008
End Date
February 1 2014
Last Update
March 10 2017
Active Locations (2)
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1
Cohen Children's Medical Cenetr of New York at North Shore
Manhasset, New York, United States, 11030
2
Cohen Children's Medical Center of New York
New Hyde Park, New York, United States, 11040