A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver… (NCT00969332) | Clinical Trial Compass
TerminatedPhase 2
A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease
Stopped: study intervention was approved by the FDA
United States62 participantsStarted 2009-08
Plain-language 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.
Who can participate
Age range2 Weeks – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Time to Reversal of Parenteral Nutrition Associated Cholestasis
Timeframe: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)