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Omegaven Expanded Access Protocol

Sponsor
St. Luke's Health System, Boise, Idaho (Other)
Overall Status
No longer available
CT.gov ID
NCT02121769
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from fish oil. It will be used in an open label compassionate use treatment protocol, as an alternative to soybean oil (omega-6), as the sole IFE source of parenteral nutrition in an effort to reduce and/or reverse parenteral nutrition associated liver disease. The study will evaluate the safety and efficacy of Omegaven use in pediatric patients with PN dependence and PNALD.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Expanded Access
Official Title:
Protocol for Patients With Parenteral Nutrition Associated Liver Disease (PNALD) to Access Parenteral Fish Oil (Omegaven®) - Omegaven IND 122375

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 17 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • 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

    • Parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of ≥ 2 mg/dL on the last two consecutive bilirubins while on PN. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.

    • Failed standard/conventional therapies to prevent progression of PNALD.

    • Age newborn to 17 years of age

    • Signed informed consent.

    Exclusion Criteria:

    • Allergy to eggs and/or shellfish

    • Female who is pregnant or lactating

    • Severe hemorrhagic disorder

    • Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency,)

    • 18 years of age or older

    • Parent/legally authorized representative is unwilling to consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Luke's Pediatric Gastroenterology Boise Idaho United States 83712

    Sponsors and Collaborators

    • St. Luke's Health System, Boise, Idaho

    Investigators

    • Principal Investigator: Tyler Burpee, MD, Pediatric Gastroenterology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tyler Burpee, MD, Principal Investigator, St. Luke's Health System, Boise, Idaho
    ClinicalTrials.gov Identifier:
    NCT02121769
    Other Study ID Numbers:
    • Omegaven Expanded Access
    First Posted:
    Apr 24, 2014
    Last Update Posted:
    Apr 10, 2019
    Last Verified:
    Apr 1, 2019
    Keywords provided by Tyler Burpee, MD, Principal Investigator, St. Luke's Health System, Boise, Idaho
    cholestasis
    short bowel syndrome
    Additional relevant MeSH terms:
    Liver Diseases

    Study Results

    No Results Posted as of Apr 10, 2019