Compassionate Use of Omegaven in Children

November 19, 2019 updated by: University of Oklahoma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • OU Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omegaven
Children will receive Omegaven at a maximum of 1 g/kg/day upon enrollment in this arm.
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.
Other Names:
  • Fish oil-based lipid
  • Omega-3-fatty acid lipid emulsion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of Cholestasis for Subjects Who Received Omegaven
Time Frame: 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)
Within the first 3 months of sole Omegaven use

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Issues for Infants Who Received Omegaven
Time Frame: 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
Within the first year of use
Essential Fatty Acid Deficiency in Infants Who Received Omegaven
Time Frame: Within the first month of use
To determine if Omegaven can resolve essential fatty acid deficiency
Within the first month of use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Collaborators

OU Medical Center

Investigators

  • Principal Investigator: Kimberly D Ernst, MD, MSMI, The University of Oklahoma, Department of Pediatrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

September 27, 2018

Study Completion (Actual)

September 27, 2019

Study Registration Dates

First Submitted

February 17, 2015

First Submitted That Met QC Criteria

February 17, 2015

First Posted (Estimate)

February 24, 2015

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 19, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5451

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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