Status:
COMPLETED
Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis
Lead Sponsor:
University of Nebraska
Conditions:
Parenteral Nutrition Associated Liver Disease PNALD
Cholestasis
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief 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 f...
Detailed Description
The primary objective of this study is to evaluate the need for and time to small bowel transplantation or liver transplantation. This will be calculated as both the age at time of primary transplant ...
Eligibility Criteria
Inclusion
- 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
- 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™
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2017
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00826020
Start Date
May 1 2009
End Date
October 6 2017
Last Update
October 5 2023
Active Locations (1)
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1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68105