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.
Male and female pediatric patients with PNAC and expected requirement of Omegaven for at least 8 weeks will be enrolled at multiple sites; PNAC is defined as being PN-dependent with a DBil level ≥ 2.0 mg/dL and no other known cause of liver dysfunction.
Other
Prospective
Omegaven® (fish oil triglycerides) Injectable Emulsion
DrugPediatric patients Pediatric patients with new-onset PNAC Drug: Omegaven® (fish oil triglycerides) Injectable Emulsion Dose, frequency and duration is a decision of the Investigator
Incidence of essential fatty acid deficiency (EFAD)
EFAD as defined by the triene:tetraene (T:T) ratio; severity of EFAD will be graded and analysed based on T:T ratio (suspected ≥ 0.05, moderate ≥ 0.20, and severe ≥ 0.40)
Incidence of clinical EFAD
Clinical EFAD is defined by clinical symptoms (like dry, scaly rash, hair loss, hair depigmentation, poor wound healing, growth restriction, and increased susceptibility to infection) and T:T ratio ≥ 0.083
Time from treatment start to EFAD diagnosis
Time from treatment start to EFAD diagnosis
Incidence of adverse events (AEs)/serious adverse events (SAEs)
The incidence of AEs/SAEs considered by the Investigator to be related to study treatment
Routine laboratory tests: Direct or conjugated bilirubin
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