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Compassionate Use of Omegaven for Pediatric Patients With Parenteral Nutrition Associated Liver Disease — Omegaven  

Short Bowel Syndrome Clinical Trial

Official title:
Intravenous Omega-3 Fatty Acid (Omegaven) for Pediatric Patients With Total Parenteral Nutrition Associated Liver Dysfunction

Clinical Trial Summary

A compassionate use protocol to provide Omegaven to pediatric patients with parenteral nutrition (PN) dependence and parenteral nutrition associated liver disease (PNALD).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01297933
Study type Expanded Access
Source Children's Hospital of Philadelphia
Contact
Status Approved for marketing
Phase
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