Compassionate Use of Omegaven in Children

Phase 2

Completed

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

• Registration Number: NCT02370251
• Lead Sponsor: University of Oklahoma

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-02-17
• Study First Submitted QC: 2015-02-17
• Study First Posted: 2015-02-24
• Study Start: 2015-06
• Primary Completion: 2018-09-27
• Results First Submitted: 2019-09-25
• Study Completion: 2019-09-27
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-19
• Last Update Submitted: 2019-11-19
• Results First Posted: 2019-11-25
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Resolution of Cholestasis for Subjects Who Received Omegaven	Within the first 3 months of sole Omegaven use	To determine if Omegaven results in the resolution of cholestasis (DB \<2 for 2 consecutive weeks)

Secondary Outcome Measures

Name	Time	Method
Safety Issues for Infants Who Received Omegaven	Within the first year of use	To determine if Omegaven results in safety issues such as increased bleeding, essential fatty acid deficiency, elevated liver function tests, increased liver and/or intestinal transplant rates, or death
Essential Fatty Acid Deficiency in Infants Who Received Omegaven	Within the first month of use	To determine if Omegaven can resolve essential fatty acid deficiency

Trial Locations

Locations (1)

OU Children's Hospital; 🇺🇸 Oklahoma City, Oklahoma, United States