Compassionate Use of Omegaven

Status Approved for marketing

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Cholestasis

Clinical Trial Details

NCT number	NCT02778698
Study type	Expanded Access
Source	Geisinger Clinic
Contact
Status	Approved for marketing
Phase

View Details

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