Clinical trial NCT00816348: Compassionate Use of Omegaven IV Fat Emulsion
Official title: Compassionate Use of Omegaven IV Fat Emulsion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cholestasis
Total Parenteral Nutrition-induced Cholestasis
Keywords: Cholestasis
Parenteral Nutrition Associated Liver Disease
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2009-01-01
Enrollment: 15
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 liver enzymes and direct bilirubin (cholestasis).

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 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.

Eligibility 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).

Primary outcomes:
measure: Level of Bilirubin
timeFrame: week 2, 3,4,and 8
Secondary outcomes:
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Cohen Children's Medical Cenetr of New York at North Shore
state: New York
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center of New York
state: New York
Study officials:
affiliation: Cohen Children's Medical Center of New York
name: Cindy Haller, MD
role: PRINCIPAL_INVESTIGATOR
References: