Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition Induced Hepatic 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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02010034|
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Liver Disease Impaired Liver Function Parenteral Nutrition Associated Liver Disease||Drug: Omegaven||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition Induced Hepatic Injury|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||February 5, 2019|
|Actual Study Completion Date :||February 5, 2019|
This lipid preparation is only being used for compassionate use.
Omegaven will be used in place of soy oil Intralipid
- Bilirubin in mg/dL [ Time Frame: 12 weeks ]
PN associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and bilirubin
1. after reaching bilirubin levels >2mg/dl, subjects receiving Omegaven will reach a bilirubin level < 2mg/dL faster that patients receiving conventional fat emulsions.
- Number of participants with adverse events [ Time Frame: 12 weeks ]
a. After starting Omegaven on PN, the rate of fatty acid deficiencies and imbalances will be as low as before Omegaven. Also, the rate of triglyceride events >400mg/dL with Omegaven will be similar to that seen with PN administration with soy oil Intralipid.
B. PN containing Omegaven will be safe for patients with respect to the risk of unexpected bleeding, coagulopathies, and other adverse events.
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): NCT02010034
|United States, Texas|
|Children's Medical Center of Dallas|
|Dallas, Texas, United States, 75235|
|Principal Investigator:||Nandini Channabasappa, MD||Childrens Health|