Compassionate Use of Omegaven® for the Treatment of Intestinal Failure Associated Liver Disease in Children
NCT02328768 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS
Last updated 2024-01-09
Summary
The overall purpose of this study is to determine if replacing standard soybean oil based fat emulsions with Omegaven®, a fish oil based fat emulsion, can reverse or prevent the progression of parenteral nutrition associated liver disease. It is a compassionate use protocol for patients who already have significant liver disease related to parenteral nutrition.
Conditions
- Total Parenteral Nutrition-Induced Cholestasis
Interventions
- DRUG
-
Omegaven
Sponsors & Collaborators
-
Children's Hospital and Medical Center, Omaha, Nebraska
collaborator OTHER -
University of Nebraska
lead OTHER
Principal Investigators
-
Brian A Jones, MD · University of Nebraska Medical Center/Children's Hospital & Medical Center
Eligibility
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
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