NCT02286596|Completed
Comparisons of Two Low-density Lipoprotein Apheresis Systems in Patients With Homozygous Familial Hypercholesterolemia
APHERESE
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APHERESE
Sponsor study identifier
observational
9
1 country
1
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2013
Actual (reported)Study Completion
December 2014
Actual (reported)Homozygous familial hypercholesterolemia (HoFH) is characterized by a six- to eight-fold raise in plasma LDL-cholesterol (LDL-C) concentrations and atherosclerotic coronary artery disease usually occur before the age of 20 if untreated. Lipid apheresis (LA) has been proved to be a reliable method to decrease LDL-C concentrations and therefore decrease cardiovascular disease risk in HoFH. The objective of this crossover study was to compare efficacy of LA performed with heparin-induced extracorporeal LDL precipitation to dextran sulfate adsorption on the reduction of lipids, inflammatory markers, adhesion molecules and LDL particles size in a cohort of HoFH subjects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
June 2013
Actual (reported)November 3, 2014
Actual (reported)November 10, 2014
Actual (reported)December 2014
Actual (reported)Change in plasma lipid levels between the two lipid apheresis treatment
At the end of the two lipid apheresis (Week 0 and 2)
Change in plasma adhesion molecule levels between the two lipid apheresis treatment
At the end of the two lipid apheresis (Week 0 and 2)
Change in plasma inflammatory marker levels between the two lipid apheresis treatment
At the end of the two lipid apheresis (Week 0 and 2)
Change in LDL particle size between the two lipid apheresis treatment
At the end of the two lipid apheresis (Week 0 and 2)
Lipid apheresis treatment for 3 hours
Lipid apheresis treatment for 3 hours
Lipid apheresis for 3 hours
Lipid apheresis for 3 hours
Patients with homozygous familial hypercholesterolemia already treated with LDL apheresis using both systems being compared (HELP vs Dextran)
Institute of Nutrition and Functional Foods (INAF)
Québec, Quebec, G1V 0A6, Canada
Patrick Couture, MD, FRCP, PhD
Laval University
9 participants (actual enrollment reported by the registry).
First Submitted
November 3, 2014
First Posted
November 10, 2014
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Study to Evaluate the Effects of MBX-8025 in Patients With HoFH
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Primary Completion
June 2013
Actual (reported)Study Completion
December 2014
Actual (reported)Last Updated
March 8, 2016
Record last verified: 2016-03
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Source: ClinicalTrials.gov.
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