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Use of Omega 3 Oil Emulsion for Parenteral Nutrition Associated Cholestasis

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.
 
ClinicalTrials.gov Identifier: NCT02148146
Expanded Access Status : No longer available
First Posted : May 28, 2014
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Diego

Brief Summary:
This is a clinical study designed to evaluate the safety and benefit of a fish oil based fat emulsion in the treatment of liver disease associated with prolonged use of intravenous nutrition.

Condition or disease Intervention/treatment
Cholestasis Drug: Omegaven

Detailed Description:

Specific Aims of Study

  1. To determine the safety profile of an intravenous omega-3 fat emulsion (Omegaven™)
  2. To determine if established 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.

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
Official Title: Clinical Trial of Omegaven™ Therapy for Parenteral Nutrition Associated Cholestasis



Intervention Details:
  • Drug: Omegaven
    Fish oil emulsion given 1g/kg/day as infusion

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:

  1. Age < 18 years old
  2. Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days, may be inpatient or outpatient
  3. Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of 2 mg/dl or more. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment
  4. Direct bilirubin > 2.0 mg/dl
  5. Signed patient informed consent
  6. The patient must have utilized standard therapies to prevent the progression of his/her liver disease including surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, or the use of ursodiol (i.e., Actigall®)

Exclusion Criteria:

  1. Pregnancy
  2. Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency)
  3. Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
  4. The parent or guardian or child unwilling to provide consent or assent
  5. Patients known to be allergic to fish or egg protein and patients with the following contraindications to Omegaven™ use:

    • Impaired lipid metabolism
    • Severe hemorrhagic disorders
    • Unstable diabetes mellitus
    • Collapse and shock
    • Stroke/embolism
    • Recent cardiac infarction
    • Undefined coma status

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): NCT02148146


Locations
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United States, California
UC San Diego Medical Center
San Diego, California, United States, 92037
Rady Children's Hospital of San Diego
San Diego, California, United States, 92123
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Sarah Lazar, MPH UC San Diego Medical Center
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Responsible Party: University of California, San Diego
ClinicalTrials.gov Identifier: NCT02148146    
Other Study ID Numbers: 105591
First Posted: May 28, 2014    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Keywords provided by University of California, San Diego:
short bowel syndrome
intestinal failure
total parenteral nutrition associated cholestasis
Additional relevant MeSH terms:
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Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases