Evaluation of Omegaven™ Parenteral Nutrition in Patients With TPN-Induced Cholestasis
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|ClinicalTrials.gov Identifier: NCT00826020|
Recruitment Status : Completed
First Posted : January 21, 2009
Last Update Posted : August 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Parenteral Nutrition Associated Liver Disease PNALD Cholestasis||Drug: Omegaven™||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Evaluation of a Parenteral Omega-3 Fatty Acid Preparation (Omegaven™) in Therapy of Patients With TPN-Induced Cholestasis|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||August 2017|
This study will be a prospective, non-randomized, open-label study of Omegaven™ for provision of parenteral lipid calories. The study cohort, receiving the PN lipid at 1g/kg/day, will be compared to historical controls at UNMC where parenteral lipid calories were provided exclusively through soybean-based formulations. The study is planned to enroll 100 patients. The Intestinal Rehabilitation Program at UNMC sees between 20 and 30 new pediatric patients per year, with almost all being PN-dependent and over 75% presenting with a bilirubin ≥ 2mg/dL. Based on these calculations, we estimate 4-5 years to enroll 100 patients.
10% Omegaven™, 50 or 100 mL bottle; 1gram/kg/day and is infused over 12-24 hours.
Other Name: Omega-3 fat emulsion
- Progression to small bowel transplantation. [ Time Frame: Bi-weekly x4, then monthly ]Whether or not the subject had an intestine-containing transplant or not
- To determine if established PN associated liver disease can be reversed or its progression halted by using a fish oil parenteral emulsion as measured by normalization of serum levels of hepatic enzymes and bilirubin. [ Time Frame: weekly x 4, then bi-weekly x4, then monthly ]Serial monitoring of liver lab values to follow the biochemical progression or regression of liver disease associated with PN.
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): NCT00826020
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68105|
|Principal Investigator:||David F Mercer, MD, PhD||University of Nebraska|