drugset / Trial / NCT02121769

Omegaven Expanded Access Protocol

NCT02121769

Expanded access No longer available St. Luke's Health System, Boise, Idaho

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.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Omegaven Other / unclassified 1 g/kg Intravenous

Indications