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Compassionate Use of Omegaven

Primary Purpose

Cholestasis

Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Omegaven
Sponsored by
Geisinger Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Cholestasis

Eligibility Criteria

15 Days - 5 Years (Child)All Sexes

Inclusion Criteria:

  1. Male or female
  2. Older than 14 days and less than 5 years of age
  3. Direct bilirubin value is greater than 2 mg/dL
  4. Be expected to require intravenous nutrition for at least an additional 28 days
  5. Parent/legal guardian has agreed to provide consent/parental permission

Exclusion Criteria:

  1. Patients who have a congenitally lethal condition (e.g. Trisomy 13).
  2. Patients who have clinically severe bleeding not able to be managed with routine measures.
  3. Patients who have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
  4. Patients who have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.

5 The parent/legal guardian is unwilling to provide consent/parental permission.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 18, 2016
    Last Updated
    March 8, 2019
    Sponsor
    Geisinger Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02778698
    Brief Title
    Compassionate Use of Omegaven
    Official Title
    Compassionate Use of an Intravenous Fat Emulsion Comprised of Fish Oil in The Treatment of Parenteral Nutrition Induced Liver Injury in Children
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Approved for marketing
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Geisinger Clinic

    4. Oversight

    5. Study Description

    Brief Summary
    This expanded access protocol is for infants or children with conditions preventing them from taking in enough nutrients from food and must receive nutrition intravenously. Standard intravenous nutrition contains fat emulsion made from soybean. If this fat emulsion is given over a long period of time, it can cause problems within the liver and if persistent and not addressed can even lead to severe and/or permanent injury to the liver. It is believed that a type of fish oil blend, called Omegaven®, may be used in place of the soybean fat blend. The Omegaven® fish oil blend may greatly reduce the risk of liver injury. Omegaven® is not approved by the Food and Drug Administration (FDA). It is only offered under an "expanded access" protocol as an alternative to the soybean fat blend.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cholestasis

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Omegaven

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Days
    Maximum Age & Unit of Time
    5 Years
    Eligibility Criteria
    Inclusion Criteria: Male or female Older than 14 days and less than 5 years of age Direct bilirubin value is greater than 2 mg/dL Be expected to require intravenous nutrition for at least an additional 28 days Parent/legal guardian has agreed to provide consent/parental permission Exclusion Criteria: Patients who have a congenitally lethal condition (e.g. Trisomy 13). Patients who have clinically severe bleeding not able to be managed with routine measures. Patients who have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis. Patients who have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves. 5 The parent/legal guardian is unwilling to provide consent/parental permission.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Edward A Everett, DO
    Organizational Affiliation
    Geisinger Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Compassionate Use of Omegaven

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