NCT02925520

Expanded Access Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Liver Injury in Children

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Cook Children's Health Care System · Academic / Other
• Sex: All
• Age: 4 Weeks – 5 Years
• Healthy volunteers: —

Summary

This is an expanded access study to assess the safety profile and changes in serum direct bilirubin levels in infants with PN associated cholestasis. Eligible patients will receive therapy with Omegaven on an expanded access basis by method of continuous infusion. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. The same standards of care provided to all patients receiving parenteral nutrition solution will be followed.

Detailed description

This expanded access protocol provides a mechanism for critically ill infants with parenteral nutrition-associated liver disease (PNALD) to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.

Conditions

• Parenteral Nutrition-Associated Liver Disease

Interventions

Type	Name	Description
DRUG	Omegaven	Therapy with Omegaven will be provided at a dose of 1 gm/kg/day infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. Parenteral fat emulsion (Intralipid) will be administered only if necessary to administer adequate calories during Omegaven therapy. The same standards of care provided to all patients receiving parenteral nutrition solution will be followed. Home Use of Omegaven: The Omegaven dose for home use will be the same as that used while in the hospital: 1 gm/kg/day. As with the inpatient part of the protocol, this is a maximum dose and may be decreased at the discretion of the provider.

Timeline

• First posted: 2016-10-06
• Last updated: 2019-01-10

Locations

1 site across 1 country: United States