NCT01194063

Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children

Use of Omegaven for Parenteral Nutrition Associated Liver Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Kapiolani Medical Center For Women & Children · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.

Detailed description

Unlike conventional intravenous fat emulsions, Omegaven™ is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV fat emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acids reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions. It is thought that by administering Omegaven™ in place of conventional phytosterol/soybean fat emulsions, cholestasis may be prevented or reversed, and patients will be able to be maintained on adequate PN for growth until they are able to ingest adequate nutrition enterally. Ongoing studies are addressing safety and efficacy of Omegaven™ in the pediatric population. In this trial, infants and children with parenteral nutrition associated liver disease will receive Omegaven™ as compassionate use to potentially prevent progression of disease. Safety and efficacy are monitored.

Conditions

• Cholestasis

Interventions

Type	Name	Description
DRUG	Omega-3 fish oil lipid emulsion	daily intravenous administration of Omegaven fish oil emulsion

Timeline

• Start date: 2010-10-20
• Primary completion: 2018-11-30
• Completion: 2019-01-15
• First posted: 2010-09-02
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study