Compassionate Use of Omegaven in Children

Short Bowel Syndrome Clinical Trial

Official title:

Fish Oil Lipid Emulsion for the Treatment of Parenteral-Nutrition-Associated Liver Disease in Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02370251
• Other study ID #: 5451
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 2015
• Est. completion date: September 27, 2019

Study information

• Verified date: November 2019
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 27, 2019
• Est. primary completion date: September 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Omegaven
Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB <2 mg/dL) occurs.

Locations

Country	Name	City	State
United States	OU Children's Hospital	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	OU Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of Cholestasis for Subjects Who Received Omegaven	To determine if Omegaven results in the resolution of cholestasis (DB <2 for 2 consecutive weeks)	Within the first 3 months of sole Omegaven use
Secondary	Safety Issues for Infants Who Received Omegaven	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	Within the first year of use
Secondary	Essential Fatty Acid Deficiency in Infants Who Received Omegaven	To determine if Omegaven can resolve essential fatty acid deficiency	Within the first month of use