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NCT02778698 Clinical Trial

Compassionate Use of Omegaven

Cholestasis Clinical Trial

Official title:
Compassionate Use of an Intravenous Fat Emulsion Comprised of Fish Oil in The Treatment of Parenteral Nutrition Induced Liver Injury in Children

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT02778698
Other study ID # OMEGAVEN
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date March 2019
Source Geisinger Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group N/A to 5 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Omegaven

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Geisinger Clinic
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