Trial Number
470-24
Condition
Digestive and Bowel Disorders
Participant Age Range
up to 18 Years
Participant Gender
Any
Enrolling Participants
Yes
Overview
“A single-arm, open-label, prospective, multicenter safety study to evaluate the occurrence of essential fatty acid deficiency (EFAD) in pediatric patients with parenteral nutrition-associated cholestasis (PNAC) who require more than eight weeks of Omegaven treatment”
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.