Compassionate Use of Omegaven IV Fat Emulsion

Cholestasis Clinical Trial

Official title:

Compassionate Use of Omegaven IV Fat Emulsion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00816348
• Other study ID #: 08-204
• Status: Terminated
• Phase: Phase 2
• First received: December 31, 2008
• Last updated: January 11, 2016
• Start date: December 2008
• Est. completion date: February 2014

Study information

• Verified date: January 2016
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholestasis
• Total Parenteral Nutrition-induced Cholestasis

Intervention

Drug:
• Omegaven
Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Cindy Haller

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of Bilirubin	measurement of bilirubin level weekly. Available data reported.	week 2, 3,4,and 8	Yes