Compassionate Use of Omegaven IV Fat Emulsion
NO_LONGER_AVAILABLE
Conditions studied: Cholestasis, Liver Disease
In brief
This protocol involves the compassionate use of intravenous fish oil infusion, Omegaven. The protocol involves infants and children with parenteral nutrition-associated liver disease to enable the reversal of elevated serum liver enzymes and direct bilirubin (cholestasis).
Key facts
- Study ID
- NCT02477345
- Run by
- Northwell Health
- Last updated by the study team
- 2017-12-08
Who can join
Age: 0 and older, up to 5. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- subjects will be infants and children from birth to 5 years of age
- diagnosis of parenteral nutrition associated liver disease (PNALD) (defined as two consecutive direct bilirubin levels of 2 mg/dl or more) in a parenteral nutrition-dependent infant or child.
- subject must have utilized standard therapies to prevent the progression of the cholestasis including reduction/removal of copper and manganese from daily PN, trial of enteral feedings if possible, and the use of ursodiol and/or phenobarbital.
You may not qualify if…
- patients are excluded if they have other documented causes of chronic liver disease (i.e.: Hepatitis C, cystic fibrosis, biliary atresia, alpha-1-anti-trypsin deficiency),
- or already have signs of proven severe advanced liver disease including cirrhosis on biopsy, varices, ascites.
- Additional exclusion criteria:
- an active coagulopathy characterized by ongoing bleeding or by a requirement for clotting factor replacement (e.g. fresh frozen plasma or cryoprecipitate) to maintain homeostasis
- impaired lipid metabolism
- severe hyperlipidemia with or without pancreatitis
- unstable diabetes mellitus
- hyperglycemia
- stroke, embolism
- collapse and shock
- recent myocardial infarction (MI)
- cholestasis due to any reason other than parenteral nutrition associated cholestasis (PNAC)
- active new infection at time of initiation of Omegaven
- hemodynamic instability
- patient cannot be enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
Where it is running
- Staten Island University Hospital — Staten Island, New York, United States
Full record on ClinicalTrials.gov
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