Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Carolinas Healthcare System
Sponsor:
Information provided by (Responsible Party):
Ricardo Caicedo, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT01845116
First received: April 29, 2013
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to determine whether the omega-3 fatty acid emulsion (Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is effective in treating parenteral nutrition associated liver disease (PNALD) in children.

The study hypothesis is that Omegaven® can be safely provided to children who are dependent on parenteral nutrition and have PNALD, and can reverse or prevent progression of PNALD until the child can take adequate nutrition by mouth.


Condition Intervention Phase
Total Parenteral Nutrition-induced 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: Use of a Fish Oil-Based Intravenous Lipid Emulsion (Omegaven®) in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury

Resource links provided by NLM:


Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • Efficacy of parenteral administration of fish oil derived fat emulsion (Omegaven®) to reverse established parenteral nutrition associated liver disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Normalization or trend toward normalization of direct bilirubin level


Estimated Enrollment: 20
Study Start Date: July 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm
Single Omegaven® Intervention Arm
Drug: Omegaven®
10% Omegaven® initiated at a starting dose of 0.5g/kg/day for two days and then advancing to the goal dose of 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
Other Name: IV Fish Oil Based Lipid Emulsion

Detailed Description:

Rationale for Omegaven® Treatment

Unlike conventional intravenous fat emulsions, Omegaven® is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV lipid emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acid reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions(1,2). By administering Omegaven® in place of conventional phytosterol/soybean fat emulsions, the cholestasis may be reversed and patients will be able to be maintained on adequate PN until they are able to ingest adequate nutrition enterally.

References

  1. Chen W. Effects of fat emulsions with different fatty acid composition on plasma and hepatic lipids in rats receiving total parenteral nutrition. Clinical Nutrition 1996;15:24.
  2. Yeh S. Effects of fish oil and safflower oil emulsions on diet-induced hepatic steatosis in rats receiving total parenteral nutrition. Clinical Nutrition 1996;15:80.
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children 0-18 years of age
  • Patients will be PN-dependent and expected to continue PN for at least 30 days
  • Patients considered eligible for study participation must have PN-associated liver diseases . Other causes of liver disease (i.e., biliary atresia, galactosemia, alpha-1 antitrypsin deficiency) will be excluded. A liver biopsy is not necessary for treatment
  • Direct bilirubin > 2.0 mg/dl
  • Signed patient informed consent
  • Signed patient assent where applicable.

Exclusion Criteria:

  • Pregnancy
  • Other causes of chronic liver disease (cystic fibrosis, biliary atresia, alpha-1 antitrypsin deficiency)
  • Signs of advanced liver disease including cirrhosis on biopsy, varices, ascites
  • The patient is allergic to eggs/shellfish
  • The patient has a severe hemorrhagic disorder
  • The patient is enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
  • The parent or guardian or child unwilling to provide consent or assent.
  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: NCT01845116

Contacts
Contact: Ricardo A. Caicedo, MD 704-381-8880 ricardo.caicedo@carolinashealthcare.org
Contact: Michelle K. Chiu, MD 704-381-4833 michelle.chiu@carolinashealthcare.org

Locations
United States, North Carolina
Levine Children's Hospital at Carolinas HealthCare System Recruiting
Charlotte, North Carolina, United States, 28232-2861
Contact: Ricardo A. Caicedo, MD    704-381-8880    ricardo.caicedo@carolinashealthcare.org   
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
Principal Investigator: Ricardo A. Caicedo, MD Levine Children's Hospital at Carolinas HealthCare System
  More Information

Publications:
Responsible Party: Ricardo Caicedo, Principal Investigator, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT01845116     History of Changes
Other Study ID Numbers: Omegaven 04-10-18B
Study First Received: April 29, 2013
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Carolinas Healthcare System:
PNALD
Cholestasis
Omegaven®
Short Bowel Syndrome

Additional relevant MeSH terms:
Cholestasis
Wounds and Injuries
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014