NCT00816348

Compassionate Use of Omegaven IV Fat Emulsion

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Cindy Haller · Academic / Other
• Sex: All
• Age: 2 Weeks – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cholestasis
• Total Parenteral Nutrition-induced Cholestasis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-12-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2009-01-01
• Last updated: 2017-03-10
• Results posted: 2016-02-09

Locations

2 sites across 1 country: United States