Expanded Access Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Liver Injury in Children

Exclusion Criteria

• •Have a congenitally lethal condition (e.g. Trisomy 13).
• •Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
• •Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.
• •Have been in another clinical trial within 30 days prior to enrollment or received an investigational drug within 30 days prior to enrollment or scheduled to receive an investigational drug other than Omegaven during the study period.
• •Severe and/or unstable concomitant systemic disease such as complex congenital cardiac disease, renal failure, autoimmune disease, sepsis, inborn error of metabolism, genetic liver disease
• •Bleeding disorder
• •Biochemical disturbance with potential of worsening with proposed treatment, e.g. persistent hyperglycemia, hypertriglyceridemia, hypercalcemia.