Compassionate Use of Omegaven in Children

Completed · Phase 2/Phase 3

Conditions studied: Total Parenteral Nutrition-induced Cholestasis, Cholestasis, Short Bowel Syndrome, Gastroschisis, Intestinal Atresia, Infant, Premature, Diseases, Cholestasis of Parenteral Nutrition

In brief

This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.

Key facts

Study ID

NCT02370251

Run by

University of Oklahoma

People needed

63

Starts

2015-06-01

Expected to finish

2019-09-27

Last updated by the study team

2019-11-25

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Live in or temporarily relocate to Oklahoma
• Age less than 18 years, both sexes, all races
• Have a direct bilirubin level of ≥2 mg/dL for two consecutive weeks after at least 14 days of parenteral nutrition
• Received parenteral lipids at a maximum dose of 1.7 g/kg/day (24 g/kg over the two weeks prior)
• Are not currently enrolled in another lipid emulsion study

You may not qualify if…

• Known food allergy to fish
• Known metabolic disorder of lipid metabolism
• Active coagulopathies (active bleeding or requiring blood product treatment in the prior 48 hours)
• Medical condition likely to result in death in the next 30 days

Where it is running

• OU Children's Hospital — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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