Compassionate Use of Omegaven in Children

• Status: Completed
• Trial end date: 2019-09-27
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Collaborator: OU Medical Center
• Treatments: Bilirubin; Soybean oil, phospholipid emulsion

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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