A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease

• Status: Terminated
• Trial end date: 2019-02-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles

Criteria

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