Compassionate Use of Omegaven
Primary Purpose
Cholestasis
Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Omegaven
Sponsored by
About this trial
This is an expanded access trial for Cholestasis
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
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
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Primary Completion Date
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Study Completion Date
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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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