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Sponsored by: |
University of Nebraska |
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Information provided by: | University of Nebraska |
ClinicalTrials.gov Identifier: | NCT00826020 |
The purpose of this study is to determine if established parenteral nutrition (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.
Condition | Intervention | Phase |
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Parenteral Nutrition Associated Liver Disease PNALD Cholestasis |
Drug: Omegaven™ |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Prospective Evaluation of a Parenteral Omega-3 Fatty Acid Preparation (Omegaven™) in Therapy of Patients With TPN-Induced Cholestasis |
Estimated Enrollment: | 100 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | August 2013 |
Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Omegaven™: Experimental |
Drug: Omegaven™
10% Omegaven™, 50 or 100 mL bottle; 1gram/kg/day and is infused over 12-24 hours.
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68105 |
Principal Investigator: | David F Mercer, MD, PhD | University of Nebraska |
Responsible Party: | University of Nebraska Medical Center ( David Mercer, MD, PhD ) |
Study ID Numbers: | 084-09-FB |
Study First Received: | January 15, 2009 |
Last Updated: | May 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00826020 History of Changes |
Health Authority: | United States: Food and Drug Administration |
PN parenteral nutrition fat emulsions |
omega-6 fatty acid liver disease fatty acid deficiency |
Liver Diseases Digestive System Diseases Bile Duct Diseases Cholestasis Biliary Tract Diseases |
Liver Diseases Digestive System Diseases Bile Duct Diseases Cholestasis Biliary Tract Diseases |