Compassionate Use of Omegaven in Children

University of Oklahoma (OU)

Status and phase: Completed; Phase 3; Phase 2

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

Treatments: Drug: Omegaven

Study type: Interventional

Funder types: Other

Identifiers

NCT02370251

5451

Details and patient eligibility

About

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.

Full description

Children up to 18 years of age, on parenteral nutrition, with a direct bilirubin level of 2 mg/dL or greater will be eligible to receive Omegaven at a maximum dose of 1 g/kg/day.

Up to 200 children will be eligible for enrollment.

Direct bilirubin levels and other labs will be monitored as well as growth parameters.

Enrollment: 63 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Omegaven

Experimental group

Description:

Children will receive Omegaven at a maximum of 1 g/kg/day upon enrollment in this arm.

Treatment:

Drug: Omegaven