Safety of Omegaven in Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (PNAC)

Exclusion Criteria

• •1. Patient has any other known cause of chronic liver disease such as hepatitis C, cystic fibrosis, biliary atresia, alpha-1-antitrypsin deficiency, passive hepatic congestion due to heart failure, etc.
• •2. Patient has known cirrhosis (liver biopsy is not required under this protocol).
• •3. Patient has known portal vein thrombosis (imaging studies are not required under this protocol).
• •4. Patient has previously received a liver-only or liver-inclusive transplant.
• •5. Patient has a major cardiac anomaly with hemodynamic instability.
• •6. Patient has a major life-threatening disease (e.g., sepsis requiring high-dose vasopressors, acute respiratory distress syndrome, veno-occlusive disease, cancer).
• •7. Patient has multi-organ failure, septic shock, hypotension requiring pressor therapy, persistent pulmonary hypertension requiring inhaled nitric oxides, or requires extracorporeal membrane oxygenation (ECMO) or similar intervention.
• •8. Patient has renal failure and requires dialysis.
• •9. Patient has a severe hemorrhagic disorder.
• •10. Patient has an INR \> 2.0.
• •11. Patient has severe hyperlipidemia or a severe disorder of lipid metabolism characterized by hypertriglyceridemia (i.e., serum triglyceride level \> 1,000 mg/dL).
• •12. Patient has a record of a previous T:T ratio ≥ 0.2 or had a previous diagnosis of EFAD.
• •13. Patient has a central nervous system anomaly (e.g., anencephaly) or any injury (e.g., grade 3 or 4 intraventricular hemorrhage, moderate to severe hypoxic ischemic encephalopathy) that will affect neurodevelopment.
• •14. Patient has been diagnosed with or is suspected to have a genetic disorder known to be associated with neurodevelopmental impairment (e.g., trisomy 21, 18, 13).
• •15. Patient has been diagnosed with or is suspected to have an inborn error of metabolism.
• •16. Patient has a known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients of Omegaven.
• •17. Patient's medical care has been deemed futile by the medical team.
• •18. Patient is enrolled in any other study with an investigational medicinal product.