Compassionate Use of Omegaven IV Fat Emulsion
|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: NCT01323907|
Recruitment Status : Withdrawn (Omegaven is now FDA approved.)
First Posted : March 28, 2011
Last Update Posted : February 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Total Parenteral Nutrition-induced Cholestasis||Drug: Omegaven IV lipid emulsion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Compassionate Use of Omegaven IV Fat Emulsion in Infants With Life Threatening Parenteral Nutrition-associated Liver Disease (PNALD).|
|Estimated Study Start Date :||January 2011|
|Actual Primary Completion Date :||February 13, 2019|
|Actual Study Completion Date :||February 13, 2019|
Omegaven IV lipid emulsion administration for infants with life threatening parenteral nutrition associated liver disease
Drug: Omegaven IV lipid emulsion
For infants meeting inclusion criteria and whose guardians consent to participation, Omegaven will be initiated at the dose of 0.5gram/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 a central or peripheral catheter alone or in conjunction with parenteral nutrition.
Other Name: Omega-3 Fatty Acids
- Reduction of direct serum bilirubin level (mg/dL) [ Time Frame: Up to 6 months from the completion of the study. ]For effectiveness endpoint, the allowable minimum time interval between serial direct bilirubin measurements that will determine reversal of cholestasis is 2 consecutive measurements of direct bilirubin < or = to 2mg/dL obtained at least 2 weeks apart.
- Essential fatty acid profile [ Time Frame: Up to 30 days from therapy completion ]Previous studies have found no association between Omegaven administration and essential fatty acid deficiency. Due to theoretical concern for developing fatty acid deficiency with low dose Omegaven administration, these levels will be followed during Omegaven therapy.
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): NCT01323907
|United States, New York|
|Columbia Presbyterian Medical Center-Children's Hospital of NY|
|New York, New York, United States, 10032|
|Principal Investigator:||Sivan Kinberg, MD, MS||Columbia University|