Status:
TERMINATED
A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease
Lead Sponsor:
University of California, Los Angeles
Conditions:
Cholestasis
Eligibility:
All Genders
2-18 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to investigate if intravenous fish oil, commercially available as Omegaven, safely and effectively reverses parenteral nutrition associated cholestasis in children.
Detailed Description
Infants dependent on parenteral nutrition for greater than 1 year who develop parenteral nutrition associated cholestasis will universally face mortality unless they receive a timely liver and/or smal...
Eligibility Criteria
Inclusion
- Clinical evidence of parenteral nutrition associated cholestasis
- Direct bilirubin greater or equal to 2 mg/dL on 2 consecutive measurements
- Expected parenteral nutrition course greater than 30 days
- Acquired or congenital gastrointestinal disease
- \> 2 weeks of age and \< 18 years of age
- \> 60% calories from parenteral nutrition
- Failed standard therapies to prevent progression of liver disease (Actigal, cyclic parenteral nutrition, avoidance of overfeeding, reduction/removal of copper from parenteral nutrition if elevated my laboratory analysis, advancement of enteral feeds)
Exclusion
- Inborn errors of metabolism
- Extracorporeal Membrane Oxygenation
- Seafood, egg, or Omegaven allergy
- Documented case of liver disease other than Parenteral Nutrition Associated Cholestasis
- Hemorrhagic disorder
- Anticoagulant therapy
- Hemodynamically unstable or in shock
- Comatose state
- Stroke, pulmonary embolism, recent myocardial infarction
- Diabetes
- Fatal chromosomal disorder
- Enrollment in any other clinical trial involving an investigational agent
- Patient, parent, or legal guardians unable or unwilling to give consent
- Patient expected to be weaned from parenteral nutrition in 30 days
- unable to tolerate necessary monitoring
- Patient requiring aspirin or toradel or motrin
- Patient requiring dialysis
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2019
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00969332
Start Date
August 1 2009
End Date
February 12 2019
Last Update
February 26 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, Los Angeles
Los Angeles, California, United States, 90095