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

Expanded access is currently available for this treatment.
Verified April 2017 by Maria Mascarenhas, Children's Hospital of Philadelphia
Sponsor:
ClinicalTrials.gov Identifier:
NCT01297933
First Posted: February 17, 2011
Last Update Posted: April 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Maria Mascarenhas, Children's Hospital of Philadelphia
February 15, 2011
February 17, 2011
April 14, 2017
 
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).
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.
Expanded Access
Drug: Omegaven
10% Omegaven 1g/kg/day, Intravenous by continuous infusion in conjunction with parenteral nutrition, until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
 
Available
Contact: Maria Mascarenhas, MBBS 215-590-2997 mascarenhas@email.chop.edu
Contact: Susan A. Becker, RN, BSN, CCRC 267-426-0269 beckers@email.chop.edu
United States
 
 
NCT01297933
Maria Mascarenhas, Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Not Provided
Principal Investigator: Maria Mascarenhas, MBBS Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
April 2017