Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment

Exclusion Criteria

• •1. Patient has received Omegaven within four weeks before inclusion in the study
• •2. 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.
• •3. Patient has known cirrhosis (liver biopsy is not required under this protocol).
• •4. Patient has been previously diagnosed with, or has prior evidence of, portal vein thrombosis.
• •5. Patient has previously received a liver-only or liver-inclusive transplant.
• •6. Patient has hemodynamic instability due to any major cardiac anomaly.
• •7. Patient has a major life-threatening disease (e.g., sepsis requiring high-dose vasopressors, acute respiratory distress syndrome, veno-occlusive disease, cancer).
• •8. 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.
• •9. Patient has renal failure and requires renal replacement therapy.
• •10. Patient has a severe hemorrhagic disorder.
• •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 EFAD before inclusion in the study
• •13. Patient has been diagnosed with or is suspected to have an inborn error of metabolism.
• •14. Patient has a known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients of Omegaven.
• •15. Patient is subject to treatment limitation.
• •16. Patient is enrolled in any other study with an investigational medicinal product during the course of the current study.