Compassionate Use of Omegaven® for the Treatment of Intestinal Failure Associated Liver Disease in Children

• Status: Completed
• Trial end date: 2018-09-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brian Jones, MD
• Collaborators: Children's Hospital & Medical Center; Children's Hospital and Medical Center, Omaha, Nebraska; University of Nebraska

Criteria

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 ≥ 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