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Expanded Access Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Liver Injury in Children

Sponsor
Cook Children's Health Care System (Other)
Overall Status
No longer available
CT.gov ID
NCT02925520
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

This is an expanded access study to assess the safety profile and changes in serum direct bilirubin levels in infants with PN associated cholestasis. Eligible patients will receive therapy with Omegaven on an expanded access basis by method of continuous infusion. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. The same standards of care provided to all patients receiving parenteral nutrition solution will be followed.

Condition or Disease Intervention/Treatment Phase

Detailed Description

This expanded access protocol provides a mechanism for critically ill infants with parenteral nutrition-associated liver disease (PNALD) to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.

Study Design

Study Type:
Expanded Access
Official Title:
Expanded Access Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Liver Injury in Children

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Weeks to 5 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Greater than 4 weeks (28 days) old and less then 5 years of age

    • Diagnosis of PNALD as defined by serum direct bilirubin greater than 2 mg/dL on 2 consecutive occasions

    • Expected to require intravenous nutrition for at least an additional 28 days

    • Have been PN-dependent for at least four weeks prior to planned Omegaven initiation

    • PN-dependent and unable to meet nutritional requirements by enteral means

    • Have failed standard therapies to prevent progression of PNALD

    • Hospitalized at time of Omegaven initiation

    Exclusion Criteria:

    • Have a congenitally lethal condition (e.g. Trisomy 13).

    • Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.

    • Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.

    • Have been in another clinical trial within 30 days prior to enrollment or received an investigational drug within 30 days prior to enrollment or scheduled to receive an investigational drug other than Omegaven during the study period.

    • Severe and/or unstable concomitant systemic disease such as complex congenital cardiac disease, renal failure, autoimmune disease, sepsis, inborn error of metabolism, genetic liver disease

    • Bleeding disorder

    • Biochemical disturbance with potential of worsening with proposed treatment, e.g. persistent hyperglycemia, hypertriglyceridemia, hypercalcemia.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cook Children's Medical Center Fort Worth Texas United States 76104

    Sponsors and Collaborators

    • Cook Children's Health Care System

    Investigators

    • Principal Investigator: Bankole O Osuntokun, MD, MS, Cook Children's Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Cook Children's Health Care System
    ClinicalTrials.gov Identifier:
    NCT02925520
    Other Study ID Numbers:
    • 2016-059
    First Posted:
    Oct 6, 2016
    Last Update Posted:
    Jan 10, 2019
    Last Verified:
    Jan 1, 2019
    Keywords provided by Cook Children's Health Care System
    Cholestasis
    Additional relevant MeSH terms:
    Liver Diseases

    Study Results

    No Results Posted as of Jan 10, 2019