Prospective Evaluation of a Parenteral Omega-3 Fatty Acid Preparation (Omegaven™) in Therapy of Patients With TPN-Induced Cholestasis

0084-09-FB

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.

2009-05-01

2017-10-06

2017-10-06

Completed

Early phase I

72

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™

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 72, 'type': 'ACTUAL'}}

2023-10-05