Compassionate Use of OmegavenĀ® for the Treatment of Intestinal Failure Associated Liver Disease iā¦ (NCT02328768) | Clinical Trial Compass
APPROVED_FOR_MARKETINGNot Applicable
Compassionate Use of OmegavenĀ® for the Treatment of Intestinal Failure Associated Liver Disease in Children
United States
Plain-language summary
The overall purpose of this study is to determine if replacing standard soybean oil based fat emulsions with OmegavenĀ®, 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 ā„ 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.
Exclusion Criteria:
* 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