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

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ClinicalTrials.gov Identifier: NCT01845116
Recruitment Status : Recruiting
First Posted : May 3, 2013
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Total Parenteral Nutrition-induced Cholestasis Drug: Omegaven® Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2010
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Efficacy of parenteral administration of fish oil derived fat emulsion (Omegaven®) to reverse established parenteral nutrition associated liver disease [ Time Frame: 6 months ]
    Normalization or trend toward normalization of direct bilirubin level


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon study completion

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

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