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

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:

MedlinePlus related topics: Liver Diseases

Drug Information available for: Liposyn II Liposyn III Omega-3 Fatty Acids

U.S. FDA Resources

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

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:

Alwayn IP, Gura K, Nosé V, Zausche B, Javid P, Garza J, Verbesey J, Voss S, Ollero M, Andersson C, Bistrian B, Folkman J, Puder M. Omega-3 fatty acid supplementation prevents hepatic steatosis in a murine model of nonalcoholic fatty liver disease. Pediatr Res. 2005 Mar;57(3):445-52. Epub 2005 Jan 19.

Van Aerde JE, Duerksen DR, Gramlich L, Meddings JB, Chan G, Thomson AB, Clandinin MT. Intravenous fish oil emulsion attenuates total parenteral nutrition-induced cholestasis in newborn piglets. Pediatr Res. 1999 Feb;45(2):202-8.

Gura KM, Parsons SK, Bechard LJ, Henderson T, Dorsey M, Phipatanakul W, Duggan C, Puder M, Lenders C. Use of a fish oil-based lipid emulsion to treat essential fatty acid deficiency in a soy allergic patient receiving parenteral nutrition. Clin Nutr. 2005 Oct;24(5):839-47.

Gura KM, Lee S, Valim C, Zhou J, Kim S, Modi BP, Arsenault DA, Strijbosch RA, Lopes S, Duggan C, Puder M. Safety and efficacy of a fish-oil-based fat emulsion in the treatment of parenteral nutrition-associated liver disease. Pediatrics. 2008 Mar;121(3):e678-86.

Diamond IR, Sterescu A, Pencharz PB, Kim JH, Wales PW. Changing the paradigm: omegaven for the treatment of liver failure in pediatric short bowel syndrome. J Pediatr Gastroenterol Nutr. 2009 Feb;48(2):209-15.

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 May 19, 2013