Compassionate Use of Omegaven IV Fat Emulsion
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|ClinicalTrials.gov Identifier: NCT00816348|
Recruitment Status : Terminated
First Posted : January 1, 2009
Results First Posted : February 9, 2016
Last Update Posted : March 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cholestasis Total Parenteral Nutrition-induced Cholestasis||Drug: Omegaven||Phase 2|
Intravenous lipids are necessary in PN (parenteral nutrition) dependent patients due to their high caloric value and essential fatty acid content. However, parenteral fat emulsions composed of soybean oils (omega 6 fatty acids) have been implicated in predisposing patients to PN associated liver disease.
It is hypothesized that by administering Omegaven®, comprised of fish oil (omega 3 fatty acids) in place of conventional soybean fat emulsion, the progression of PN-associated cholestasis may be prevented or reversed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Compassionate Use of Omegaven IV Fat Emulsion|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
All subjects will receive Omegaven
Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day.
- Level of Bilirubin [ Time Frame: week 2, 3,4,and 8 ]measurement of bilirubin level weekly. Available data reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816348
|United States, New York|
|Cohen Children's Medical Cenetr of New York at North Shore|
|Manhasset, New York, United States, 11030|
|Cohen Children's Medical Center of New York|
|New Hyde Park, New York, United States, 11040|
|Principal Investigator:||Cindy Haller, MD||Cohen Children's Medical Center of New York|