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Compassionate Use of Omegaven in Children | Clinical Trials | Clareo Health

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COMPLETEDPhase 2/3NCT02370251

Compassionate Use of Omegaven in Children

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.

Lead sponsor: University of Oklahoma•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of Oklahoma

Collaborators

OU Medical Center

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.

Age

0 - 18 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 25, 2019Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2/PHASE3

Enrollment63

Start dateJun 2015

Last updatedNov 25, 2019

Condition

Total Parenteral Nutrition-induced Cholestasis Cholestasis Short Bowel Syndrome Gastroschisis Intestinal Atresia+2 more

Locations shown

OU Children's Hospital

Oklahoma City, Oklahoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2019Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions