Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury

• Status: Completed
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the omega-3 fatty acid emulsion (Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is effective in treating parenteral nutrition associated liver disease (PNALD) in children.

The study hypothesis is that Omegaven® can be safely provided to children who are dependent on parenteral nutrition and have PNALD, and can reverse or prevent progression of PNALD until the child can take adequate nutrition by mouth.

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

Details

• Lead Sponsor: Atrium Health; Carolinas Healthcare System

Criteria

Inclusion Criteria:

• Children 0-18 years of age

• Patients will be PN-dependent and expected to continue PN for at least 30 days

• Patients considered eligible for study participation must have PN-associated liver diseases . Other causes of liver disease (i.e., biliary atresia, galactosemia, alpha-1 antitrypsin deficiency) will be excluded. A liver biopsy is not necessary for treatment

• Direct bilirubin > 2.0 mg/dl

• Signed patient informed consent

• Signed patient assent where applicable.

Exclusion Criteria:

• Pregnancy

• Other causes of chronic liver disease (cystic fibrosis, biliary atresia, alpha-1 antitrypsin deficiency)

• Signs of advanced liver disease including cirrhosis on biopsy, varices, ascites

• The patient is allergic to eggs/shellfish

• The patient has a severe hemorrhagic disorder

• The patient is enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)

• The parent or guardian or child unwilling to provide consent or assent.