Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease

Children's Mercy Hospital Kansas City2 enrolled

Overview

To provide parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) to patients with liver disease (PNALD).

This is a compassionate use protocol for patients with PNALD who have failed traditional treatment to receive Omegaven through an IND. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parenteral Nutrition-related Hepatitis

Interventions

OmegavenDRUG

Expanded Access Therapy with Omegaven will be initiated at a starting dose of 0.5 gm/kg/day to be infused over 24 hrs. After two days of infusion the dose will be increased to 1gm/kg/day.

Eligibility

Sex: ALLMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. The patient will be PN dependent and unable to meet nutritional needs solely by enteral nutrition. 2. Patient will be \<18 years of age. 3. Direct bilirubin \> 2.0mg/dl 4. The patient must have failed standard therapies to prevent progression his/her liver disease. Exclusion Criteria: 1. Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency). 2. Patients who are allergic to eggs/shellfish 3. Patients who have severe hemorrhagic disorders.

Locations (1)

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Outcomes

Primary Outcomes

Disease Progression as Measured by Serum Levels of Hepatic Enzymes

To evaluate whether established parenteral nutrition associated liver disease (PNALD) can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) as measured by normalization or decrease of serum levels of hepatic enzymes.

Time frame: Up to 1 year

Data from ClinicalTrials.gov

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