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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Mercer, MD, PhD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT00826020
First received: January 15, 2009
Last updated: August 17, 2017
Last verified: August 2017
  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: Intervention Model: Single Group Assignment
Masking: None (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 David Mercer, MD, PhD, University of Nebraska:

Primary Outcome Measures:
  • Progression to small bowel transplantation. [ Time Frame: Bi-weekly x4, then monthly ]
    Whether or not the subject had an intestine-containing transplant or not


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 ]
    Serial monitoring of liver lab values to follow the biochemical progression or regression of liver disease associated with PN.


Enrollment: 85
Study Start Date: April 2009
Study Completion Date: August 2017
Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Mercer, MD, PhD, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT00826020     History of Changes
Other Study ID Numbers: 084-09-FB
Study First Received: January 15, 2009
Last Updated: August 17, 2017

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

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

ClinicalTrials.gov processed this record on September 21, 2017