Clinical Trial: Use of Omega 3 Oil Emulsion for Parenteral Nutrition Associated Cholestasis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Clinical Trial of Omegaven™ Therapy for Parenteral Nutrition Associated Cholestasis
Brief Summary: This is a clinical study designed to evaluate the safety and benefit of a fish oil based fat emulsion in the treatment of liver disease associated with prolonged use of intravenous nutrition.
Detailed Summary:
Specific Aims of Study
- To determine the safety profile of an intravenous omega-3 fat emulsion (Omegaven™)
- To determine if established PN associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and bilirubin.
Sponsor: University of California, San Diego
Current Primary Outcome: Duration of elevated direct bilirubin [ Time Frame: Weekly until direct bilirubin below 2 mg/dL, average treatment for 2 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of California, San Diego
Dates:
Date Received: May 20, 2014
Date Started: March 2011
Date Completion: December 2018
Last Updated: May 1, 2017
Last Verified: May 2017
