drugset / Trial / NCT02929303

Expanded Access of Omegaven IV Fat Emulsion to Infants and Children With PNALD

NCT02929303

Expanded access Approved for marketing Wake Forest University Health Sciences

Summary

This is an expanded access protocol for use of intravenous fish oil infusion, Omegaven, in infants and children with parenteral nutrition associated liver disease (PNALD) to decrease elevated liver enzymes and direct bilirubin. This study aims to describe the response of PNALD after use of Omegaven by normalization of serum levels of liver enzymes and bilirubin.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Omegaven Other / unclassified 1 g/kg Intravenous