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 2017|
|Estimated Primary Completion Date:||January 2017 (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297933
|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|