Compassionate Use of Omegaven in Children
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|ClinicalTrials.gov Identifier: NCT02370251|
Recruitment Status : Recruiting
First Posted : February 24, 2015
Last Update Posted : December 21, 2017
|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)|
|Estimated Enrollment :||200 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|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
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 [ 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 [ 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 triglyceride levels, elevated liver function tests, increased liver and/or intestinal transplant rates, or death
- Essential fatty acid deficiency [ 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
|Contact: Kimberly D Ernst, MD, MSMI||405-271-5215 ext email@example.com|
|Contact: Susan Bedwell, APRNfirstname.lastname@example.org|
|United States, Oklahoma|
|OU Children's Hospital||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Kimberly D Ernst, MD 405-271-5266 email@example.com|
|Contact: Ashley N Anderson, RN, BSN 405-271-5215 ext 42199 firstname.lastname@example.org|
|Principal Investigator:||Kimberly D Ernst, MD, MSMI||The University of Oklahoma, Department of Pediatrics|