Compassionate Use of Omegaven® for the Treatment of Intestinal Failure Associated Liver Disease in Children
APPROVED_FOR_MARKETING
Conditions studied: Total Parenteral Nutrition-Induced Cholestasis
In brief
The overall purpose of this study is to determine if replacing standard soybean oil based fat emulsions with Omegaven®, a fish oil based fat emulsion, can reverse or prevent the progression of parenteral nutrition associated liver disease. It is a compassionate use protocol for patients who already have significant liver disease related to parenteral nutrition.
Key facts
- Study ID
- NCT02328768
- Run by
- University of Nebraska
- Last updated by the study team
- 2024-01-09
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Parenteral nutrition (PN) dependent (unable to meet nutritional needs solely by enteral nutrition) and expected to require PN for at least another 30 days.
- Parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin ≥ 2mg/dL or by histology and/or currently on Omegaven through another protocol.
- Other causes of liver disease have been excluded. A liver biopsy is not necessary for treatment.
- Exhaustion of standard therapies to prevent the progression of the liver disease including surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese form PN, advancement of enteral feeding, and the use of ursodiol.
You may not qualify if…
- Pregnancy
- Other causes of liver disease
- Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
- The parent/guardian or subject is unwilling to provide consent and assent
Where it is running
- Children's Hospital & Medical Center — Omaha, Nebraska, United States
Full record on ClinicalTrials.gov
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