Status:
COMPLETED
Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease
Lead Sponsor:
Children's Mercy Hospital Kansas City
Conditions:
Parenteral Nutrition-related Hepatitis
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE2
PHASE3
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04697888
Start Date
April 1 2013
End Date
November 1 2018
Last Update
June 11 2021
Active Locations (1)
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1
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108