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Compassionate Use of Omegaven in Children

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ClinicalTrials.gov Identifier: NCT02370251
Recruitment Status : Recruiting
First Posted : February 24, 2015
Last Update Posted : December 21, 2017
Sponsor:
Collaborator:
OU Medical Center
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Total Parenteral Nutrition-induced Cholestasis Cholestasis Short Bowel Syndrome Gastroschisis Intestinal Atresia Infant, Premature, Diseases Cholestasis of Parenteral Nutrition Drug: Omegaven Phase 2 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fish Oil Lipid Emulsion for the Treatment of Parenteral-Nutrition-Associated Liver Disease in Infants
Study Start Date : June 2015
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021


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




Primary Outcome Measures :
  1. Resolution of cholestasis [ 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)


Secondary Outcome Measures :
  1. Safety issues [ 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 triglyceride levels, elevated liver function tests, increased liver and/or intestinal transplant rates, or death

  2. Essential fatty acid deficiency [ Time Frame: Within the first month of use ]
    To determine if Omegaven can resolve essential fatty acid deficiency



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370251


Contacts
Contact: Kimberly D Ernst, MD, MSMI 405-271-5215 ext 42039 omegaven@ouhsc.edu
Contact: Susan Bedwell, APRN 405-271-6169 susan.bedwell@oumedicine.com

Locations
United States, Oklahoma
OU Children's Hospital Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Kimberly D Ernst, MD    405-271-5266    omegaven@ouhsc.edu   
Contact: Ashley N Anderson, RN, BSN    405-271-5215 ext 42199    ashley-n-anderson@ouhsc.edu   
Sponsors and Collaborators
University of Oklahoma
OU Medical Center
Investigators
Principal Investigator: Kimberly D Ernst, MD, MSMI The University of Oklahoma, Department of Pediatrics

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT02370251     History of Changes
Other Study ID Numbers: 5451
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017

Keywords provided by University of Oklahoma:
Fat Emulsions, Intravenous
Parenteral-Nutrition-Associated Liver Disease
Cholestasis
Omegaven
Fish Oil

Additional relevant MeSH terms:
Cholestasis
Short Bowel Syndrome
Gastroschisis
Infant, Premature, Diseases
Intestinal Atresia
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Postoperative Complications
Pathologic Processes
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical
Infant, Newborn, Diseases
Digestive System Abnormalities