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Completed

NCT Number: NCT04697888

Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease

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

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Key information

Conditions

Parenteral Nutrition-related Hepatitis

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient will be PN dependent and unable to meet nutritional needs solely by enteral nutrition.
  • Patient will be <18 years of age.
  • Direct bilirubin > 2.0mg/dl
  • The patient must have failed standard therapies to prevent progression his/her liver disease.

Exclusion criteria

  • Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency).
  • Patients who are allergic to eggs/shellfish
  • Patients who have severe hemorrhagic disorders.

Treatment and study plan

Omegaven

Drug

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.

Other names: IV Fish Oil Based Lipid Emulsion

Primary outcomes

  1. Disease Progression as Measured by Serum Levels of Hepatic Enzymes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jan 6, 2021
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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