Other Clinical Trial - Compassionate Use of Omegaven IV Fat Emulsion

Status Terminated

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).

Clinical Trial 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. ;

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

Clinical Trial Details

NCT number	NCT00816348
Study type	Interventional
Source	Northwell Health
Contact
Status	Terminated
Phase	Phase 2
Start date	December 2008
Completion date	February 2014

View Details

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