Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease

Phase 2

Completed

• Conditions: Parenteral Nutrition-related Hepatitis
• Interventions: Drug: Omegaven

• Registration Number: NCT04697888
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2013-04
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-06
• Results First Submitted: 2021-01-07
• Results First Submitted QC: 2021-02-19
• Results First Posted: 2021-03-12
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-01
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Overall Study	Omegaven	Use of Omegaven for patients with parenteral nutrition associated liver disease.

Primary Outcome Measures

Name	Time	Method
Disease Progression as Measured by Serum Levels of Hepatic Enzymes	Up to 1 year	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.

Trial Locations

Locations (1)

Children's Mercy Hospitals and Clinics; 🇺🇸 Kansas City, Missouri, United States