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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00826020
First received: January 15, 2009
Last updated: May 4, 2009
Last verified: May 2009
  Purpose

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
Cholestasis
Drug: Omegaven™
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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™
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826020

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Mercer, MD, PhD, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00826020     History of Changes
Other Study ID Numbers: 084-09-FB
Study First Received: January 15, 2009
Last Updated: May 4, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Cholestasis
Liver Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014