Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis

• Status: Completed
• Trial end date: 2017-10-06
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if established parenteral nutrition (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.

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

Details

• Lead Sponsor: University of Nebraska

Criteria

Inclusion Criteria:

• Patients must be enrolled in the Intestinal Rehabilitation Program at the University of Nebraska Medical Center, AND:

• Be unable to meet nutritional needs solely by enteral nutrition and be expected to require PN for at least another 30 days

• Have clinical evidence of parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of 2 mg/dl or more. A liver biopsy is desirable but not necessary for treatment

• Signed patient informed consent

Exclusion Criteria:

• Parent or guardian or child unwilling to provide consent or assent

• Inability or unwillingness on the part of parent/guardian or child to follow clinical recommendations of the Intestinal Rehabilitation Program

• Allergies or clinical conditions precluding safe use of Omegaven™