Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury
|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.|
|ClinicalTrials.gov Identifier: NCT01845116|
Recruitment Status : Recruiting
First Posted : May 3, 2013
Last Update Posted : July 17, 2017
The purpose of this study is to determine whether the omega-3 fatty acid emulsion (Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is effective in treating parenteral nutrition associated liver disease (PNALD) in children.
The study hypothesis is that Omegaven® can be safely provided to children who are dependent on parenteral nutrition and have PNALD, and can reverse or prevent progression of PNALD until the child can take adequate nutrition by mouth.
|Condition or disease||Intervention/treatment||Phase|
|Total Parenteral Nutrition-induced Cholestasis||Drug: Omegaven®||Phase 2|
Rationale for Omegaven® Treatment
Unlike conventional intravenous fat emulsions, Omegaven® is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV lipid emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acid reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions(1,2). By administering Omegaven® in place of conventional phytosterol/soybean fat emulsions, the cholestasis may be reversed and patients will be able to be maintained on adequate PN until they are able to ingest adequate nutrition enterally.
- Chen W. Effects of fat emulsions with different fatty acid composition on plasma and hepatic lipids in rats receiving total parenteral nutrition. Clinical Nutrition 1996;15:24.
- Yeh S. Effects of fish oil and safflower oil emulsions on diet-induced hepatic steatosis in rats receiving total parenteral nutrition. Clinical Nutrition 1996;15:80.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of a Fish Oil-Based Intravenous Lipid Emulsion (Omegaven®) in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2025|
Single Omegaven® Intervention Arm
10% Omegaven® initiated at a starting dose of 0.5g/kg/day for two days and then advancing to the goal dose of 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
Other Name: IV Fish Oil Based Lipid Emulsion
- Efficacy of parenteral administration of fish oil derived fat emulsion (Omegaven®) to reverse established parenteral nutrition associated liver disease [ Time Frame: 6 months ]Normalization or trend toward normalization of direct bilirubin level
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845116
|Contact: Ricardo A. Caicedo, MDemail@example.com|
|Contact: Michelle K. Chiu, MDfirstname.lastname@example.org|
|United States, North Carolina|
|Levine Children's Hospital at Carolinas HealthCare System||Recruiting|
|Charlotte, North Carolina, United States, 28232-2861|
|Contact: Ricardo A. Caicedo, MD 704-381-8880 email@example.com|
|Principal Investigator:||Ricardo A. Caicedo, MD||Levine Children's Hospital at Carolinas HealthCare System|