Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease

Completed · Phase 2/Phase 3

Conditions studied: Parenteral Nutrition-related Hepatitis

In brief

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

Key facts

Study ID

NCT04697888

Run by

Children's Mercy Hospital Kansas City

People needed

2

Starts

2013-04-01

Expected to finish

2018-11-01

Last updated by the study team

2021-06-11

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Mercy Hospitals and Clinics — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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