Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease

Parenteral Nutrition-related Hepatitis Clinical Trial

Official title:

Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04697888
• Other study ID #: 12010063
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 2013
• Est. completion date: November 2018

Study information

• Verified date: June 2021
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Diseases
• Parenteral Nutrition-related Hepatitis

Intervention

Drug:
• Omegaven
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.

Locations

Country	Name	City	State
United States	Children's Mercy Hospitals and Clinics	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 1 year