Compassionate Use of Omegaven in Children
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|ClinicalTrials.gov Identifier: NCT02370251|
Recruitment Status : Completed
First Posted : February 24, 2015
Results First Posted : November 25, 2019
Last Update Posted : November 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Total Parenteral Nutrition-induced Cholestasis Cholestasis Short Bowel Syndrome Gastroschisis Intestinal Atresia Infant, Premature, Diseases Cholestasis of Parenteral Nutrition||Drug: Omegaven||Phase 2 Phase 3|
Children up to 18 years of age, on parenteral nutrition, with a direct bilirubin level of 2 mg/dL or greater will be eligible to receive Omegaven at a maximum dose of 1 g/kg/day.
Up to 200 children will be eligible for enrollment.
Direct bilirubin levels and other labs will be monitored as well as growth parameters.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fish Oil Lipid Emulsion for the Treatment of Parenteral-Nutrition-Associated Liver Disease in Infants|
|Actual Study Start Date :||June 2015|
|Actual Primary Completion Date :||September 27, 2018|
|Actual Study Completion Date :||September 27, 2019|
Children will receive Omegaven at a maximum of 1 g/kg/day upon enrollment in this arm.
Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB <2 mg/dL) occurs.
- Resolution of Cholestasis for Subjects Who Received Omegaven [ Time Frame: Within the first 3 months of sole Omegaven use ]To determine if Omegaven results in the resolution of cholestasis (DB <2 for 2 consecutive weeks)
- Safety Issues for Infants Who Received Omegaven [ Time Frame: Within the first year of use ]To determine if Omegaven results in safety issues such as increased bleeding, essential fatty acid deficiency, elevated liver function tests, increased liver and/or intestinal transplant rates, or death
- Essential Fatty Acid Deficiency in Infants Who Received Omegaven [ Time Frame: Within the first month of use ]To determine if Omegaven can resolve essential fatty acid deficiency
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): NCT02370251
|United States, Oklahoma|
|OU Children's Hospital|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||Kimberly D Ernst, MD, MSMI||The University of Oklahoma, Department of Pediatrics|