NCT02010034

Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition Induced Hepatic Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Children's Medical Center Dallas · Academic / Other
• Sex: All
• Age: 2 Months – 10 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to determine if an investigational study drug called Omegaven can help to improve liver disease thought to be caused by Total Parenteral Nutrition (TPN). TPN is intravenous feeding (IV feeding tube) that provides patients the nutrients when they are unable to drink fluid or eat food by mouth.

Detailed description

PAtients with direct bilirubin \>2gm/dL and short bowel syndrome are eligible for enrollment. Omegaven at 1gm/kg/day will be administered via central venous line instead of standard lipid preparations.

Conditions

• Liver Disease
• Impaired Liver Function
• Parenteral Nutrition Associated Liver Disease

Interventions

Type	Name	Description
DRUG	Omegaven	Omegaven will be used in place of soy oil Intralipid

Timeline

• Start date: 2013-08-01
• Primary completion: 2019-02-05
• Completion: 2019-02-05
• First posted: 2013-12-12
• Last updated: 2019-02-06

Locations

1 site across 1 country: United States