Clincosm LogoSign in Get a demo

Use of Omega 3 Oil Emulsion for Parenteral Nutrition Associated Cholestasis

Sponsor
University of California, San Diego (Other)
Overall Status
No longer available
CT.gov ID
NCT02148146
Collaborator
(none)
2
Locations

Study Details

Study Description

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 Phase

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.

Study Design

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UC San Diego Medical Center San Diego California United States 92037
    2 Rady Children's Hospital of San Diego San Diego California United States 92123

    Sponsors and Collaborators

    • University of California, San Diego

    Investigators

    • Principal Investigator: Sarah Lazar, MPH, UC San Diego Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Diego
    ClinicalTrials.gov Identifier:
    NCT02148146
    Other Study ID Numbers:
    • 105591
    First Posted:
    May 28, 2014
    Last Update Posted:
    Jan 12, 2021
    Last Verified:
    Jan 1, 2021
    Keywords provided by University of California, San Diego
    short bowel syndrome
    intestinal failure
    total parenteral nutrition associated cholestasis
    Additional relevant MeSH terms:
    Cholestasis

    Study Results

    No Results Posted as of Jan 12, 2021