CompletedPhase 2

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

United States72 participantsStarted 2009-05-01

Plain-language 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.

Who can participate

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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™

What they're measuring

Number of Patients With Progression to Small Bowel Transplantation.

Timeframe: Bi-weekly x4, then monthly until the completion of the study, for an overall average of 5.5 years follow-up for the cohort

Trial details

NCT IDNCT00826020

SponsorUniversity of Nebraska

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10-06

Results submitted2019-04-22

View on ClinicalTrials.gov More Parenteral Nutrition Associated Liver Disease PNALD trials