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Trial record 28 of 69 for:    tpn

Safer Parenteral Nutrition in Pediatric Short Bowel Syndrome to Decrease Liver Damage

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01861834
Expanded Access Status : Approved for marketing
First Posted : May 24, 2013
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Georgetown University

Tracking Information
First Submitted Date May 22, 2013
First Posted Date May 24, 2013
Last Update Posted Date May 7, 2019
 
Descriptive Information
Brief Title Safer Parenteral Nutrition in Pediatric Short Bowel Syndrome to Decrease Liver Damage
Brief Summary To provide children dependent on total parenteral nutrition with Omegaven®, a fish oil-based intravenous lipid emulsion that may be less hepatotoxic than conventional, vegetable oil-based intravenous lipid emulsions, and that may therefore reduce the need for liver transplantation.
Detailed Description Not Provided
Study Type Expanded Access
Intervention Drug: Omegaven 10%

Patients with a sustained TPN requirement due to short bowel syndrome and TPN-associated liver disease that threatens progression to liver failure and death, for which the only available means of prevention at present is timely liver and/or intestinal transplant.

Omegaven 10%, 1 gram/kg, IV, every 12 hours until transplantation, or stopping TPN

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Approved for marketing
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01861834
Responsible Party Georgetown University
Study Sponsor Georgetown University
Collaborators Not Provided
Investigators Not Provided
PRS Account Georgetown University
Verification Date May 2019