NCT02121769

Omegaven Expanded Access Protocol

Protocol for Patients With Parenteral Nutrition Associated Liver Disease (PNALD) to Access Parenteral Fish Oil (Omegaven®) - Omegaven IND 122375

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: St. Luke's Health System, Boise, Idaho · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: —

Summary

Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from fish oil. It will be used in an open label compassionate use treatment protocol, as an alternative to soybean oil (omega-6), as the sole IFE source of parenteral nutrition in an effort to reduce and/or reverse parenteral nutrition associated liver disease. The study will evaluate the safety and efficacy of Omegaven use in pediatric patients with PN dependence and PNALD.

Conditions

• Parenteral Nutrition Associated Liver Disease

Interventions

Type	Name	Description
DRUG	Omegaven	10% Omegaven 1g/kg/day, Intravenous by continuous infusion in conjunction with parenteral nutrition, until the patient no longer requires parenteral nutrition or until participation in the study is terminated.

Timeline

• First posted: 2014-04-24
• Last updated: 2019-04-10

Locations

1 site across 1 country: United States