This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population
Patient's parent(s) or legal guardian(s) has provided a signed and dated Informed Consent Form (ICF).
Pediatric patient (<18 years) has been diagnosed with PNAC, defined as direct or conjugated bilirubin (DBil) ≥ 2.0 mg/dL with no other known cause of liver dysfunction at the time of enrollment and is expected to require Omegaven treatment for at least eight weeks.
Patient has oral or enteral feeding intolerance or at least one gastrointestinal disorder requiring PN.
Patient has received Omegaven within four weeks before inclusion in the study
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.
Patient has known cirrhosis (liver biopsy is not required under this protocol).
Patient has been previously diagnosed with, or has prior evidence of, portal vein thrombosis.
Fresenius Kabi
Lead sponsor