A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease
Stopped early · Phase 2
Conditions studied: Cholestasis
In brief
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.
Key facts
- Study ID
- NCT00969332
- Run by
- University of California, Los Angeles
- People needed
- 62
- Starts
- 2009-08-01
- Expected to finish
- 2019-02-12
- Last updated by the study team
- 2020-02-26
Who can join
Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- University of California, Los Angeles — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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