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
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Primary completion
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Completion
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Drugs

EvaluationDrugModalityDoseRoute
Subject Omegaven Other / unclassified 1 g/kg Intravenous

Indications