Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 15, 2009
May 4, 2009
April 2009
August 2013   (final data collection date for primary outcome measure)
Progression to small bowel transplantation. [ Time Frame: Bi-weekly x4, then monthly ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00826020 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of Omegaven™ Parenteral Nutrition in Patients With TPN-Induced Cholestasis
Prospective Evaluation of a Parenteral Omega-3 Fatty Acid Preparation (Omegaven™) in Therapy of Patients With TPN-Induced Cholestasis

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Parenteral Nutrition Associated Liver Disease PNALD
  • Cholestasis
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
Experimental: Omegaven™
Intervention: Drug: Omegaven™

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
100
August 2013
August 2013   (final data collection date for primary outcome measure)

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™
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00826020
084-09-FB
Yes
David Mercer, MD, PhD, University of Nebraska Medical Center
University of Nebraska
Not Provided
Principal Investigator: David F Mercer, MD, PhD University of Nebraska
University of Nebraska
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP