Compassionate Use of Omegaven for Pediatric Patients With Parenteral Nutrition Associated Liver Disease
A compassionate use protocol to provide Omegaven to pediatric patients with parenteral nutrition (PN) dependence and parenteral nutrition associated liver disease (PNALD).
|Study Type:||Expanded Access What is Expanded Access?|
|Official Title:||Intravenous Omega-3 Fatty Acid (Omegaven) for Pediatric Patients With Total Parenteral Nutrition Associated Liver Dysfunction|
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from fish oil. It will be used in an open label compassionate use treatment protocol, as an alternative to soybean oil (omega-6), as the sole IFE source of parenteral nutrition in an effort to reduce and/or reverse parenteral nutrition associated liver disease. The study will evaluate the safety and efficacy of Omegaven use in pediatric patients with PN dependence and PNALD.
|Contact: Maria Mascarenhas, MBBSfirstname.lastname@example.org|
|Contact: Debbie Kawchakemail@example.com|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator: Maria Mascarenhas, MBBS|
|Principal Investigator:||Maria Mascarenhas, MBBS||Children's Hospital of Philadelphia|