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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by University of Nebraska.
Recruitment status was:  Enrolling by invitation
Information provided by:
University of Nebraska Identifier:
First received: January 15, 2009
Last updated: May 4, 2009
Last verified: May 2009
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.

Condition Intervention Phase
Parenteral Nutrition Associated Liver Disease PNALD
Drug: Omegaven™
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Evaluation of a Parenteral Omega-3 Fatty Acid Preparation (Omegaven™) in Therapy of Patients With TPN-Induced Cholestasis

Resource links provided by NLM:

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Progression to small bowel transplantation. [ Time Frame: Bi-weekly x4, then monthly ]

Secondary Outcome Measures:
  • To determine if established PN associated liver disease can be reversed or its progression halted by using a fish oil parenteral emulsion as measured by normalization of serum levels of hepatic enzymes and bilirubin. [ Time Frame: weekly x 4, then bi-weekly x4, then monthly ]

Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omegaven™ Drug: Omegaven™
10% Omegaven™, 50 or 100 mL bottle; 1gram/kg/day and is infused over 12-24 hours.
Other Name: Omega-3 fat emulsion


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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™
  Contacts and Locations
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Please refer to this study by its identifier: NCT00826020

United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68105
Sponsors and Collaborators
University of Nebraska
Principal Investigator: David F Mercer, MD, PhD University of Nebraska
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: David Mercer, MD, PhD, University of Nebraska Medical Center Identifier: NCT00826020     History of Changes
Other Study ID Numbers: 084-09-FB
Study First Received: January 15, 2009
Last Updated: May 4, 2009

Keywords provided by University of Nebraska:
parenteral nutrition
fat emulsions
omega-6 fatty acid
liver disease
fatty acid deficiency

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases processed this record on May 25, 2017