An expanded access record providing Omegaven in Cholestasis, sponsored by Geisinger Clinic. Approved for marketing. Open to participants aged 15 Days to 5 Years. Per ClinicalTrials.gov, last updated 2019-03-12.
Sponsored by Geisinger Clinic · Expanded access
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.
222 studies on the registry are indexed under Cholestasis; 36 are open to participants now.
Browse Cholestasis studies →Geisinger Clinic is the lead sponsor of 127 studies on the registry; 19 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
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Exclusion Criteria:
5 The parent/legal guardian is unwilling to provide consent/parental permission.
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