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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00826020
First Posted: January 21, 2009
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David Mercer, MD, PhD, University of Nebraska
January 15, 2009
January 21, 2009
August 22, 2017
April 2009
August 2017   (Final data collection date for primary outcome measure)
Progression to small bowel transplantation. [ Time Frame: Bi-weekly x4, then monthly ]
Whether or not the subject had an intestine-containing transplant or not
Progression to small bowel transplantation. [ Time Frame: Bi-weekly x4, then monthly ]
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 ]
Serial monitoring of liver lab values to follow the biochemical progression or regression of liver disease associated with PN.
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 ]
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.
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 as well as the length of time from initial evaluation to transplant.Secondary objectives are to determine if there are improvements in clinical measures associated with established parenteral nutrition- associated liver disease (PNALD). These will be determined by measurement of total and direct bilirubin levels, platelet count, serum albumin, and changes in both length and weight growth curves.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (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™
This study will be a prospective, non-randomized, open-label study of Omegaven™ for provision of parenteral lipid calories. The study cohort, receiving the PN lipid at 1g/kg/day, will be compared to historical controls at UNMC where parenteral lipid calories were provided exclusively through soybean-based formulations. The study is planned to enroll 100 patients. The Intestinal Rehabilitation Program at UNMC sees between 20 and 30 new pediatric patients per year, with almost all being PN-dependent and over 75% presenting with a bilirubin ≥ 2mg/dL. Based on these calculations, we estimate 4-5 years to enroll 100 patients.
Intervention: Drug: Omegaven™

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
August 2017
August 2017   (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™
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00826020
084-09-FB
Yes
Not Provided
Not Provided
David Mercer, MD, PhD, University of Nebraska
University of Nebraska
Not Provided
Principal Investigator: David F Mercer, MD, PhD University of Nebraska
University of Nebraska
August 2017

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