Overview
Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease
Status:
Completed
Completed
Trial end date:
2018-11-01
2018-11-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
To provide parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) to patients with liver disease (PNALD).Phase:
Phase 2/Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Children's Mercy Hospital Kansas City
Criteria
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.