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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 April 2016 |
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Main ID: |
NCT02286596 |
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Date of registration:
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03/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparisons of Two Low-density Lipoprotein Apheresis Systems in Patients With Homozygous Familial Hypercholesterolemia
APHERESE |
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Scientific title:
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Comparisons of Two Low-density Lipoprotein Apheresis Systems in Patients With Homozygous Familial Hypercholesterolemia |
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Date of first enrolment:
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April 2013 |
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Target sample size:
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9 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02286596 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Crossover, Time Perspective: Retrospective
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Patrick Couture, MD, FRCP, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Laval University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Aged between 18-65 years
- Subjects with homozygous familial hypercholesterolemia:
- Carrier of a mutation in the LDL receptor gene
Exclusion Criteria:
- Subjects with a previous history of cardiovascular disease
- Subjects with Type 2 diabetes
- Were pregnant or nursing;
- Subjects with a history of cancer
- Subjects with acute liver disease, hepatic dysfunction, or persistent elevations of
serum transaminases
- Subjects with a secondary hyperlipidemia due to any cause
- History of alcohol or drug abuse within the past 2 years
- hormonal treatment
- Subjects who are in a situation or have any condition that, in the opinion of the
investigator, may interfere with optimal participation in the study
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Homozygous Familial Hypercholesterolemia
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Intervention(s)
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Device: dextran sulfate adsorption
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Device: heparin-induced extracorporeal LDL precipitation
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Primary Outcome(s)
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Change in plasma lipid levels between the two lipid apheresis treatment
[Time Frame: At the end of the two lipid apheresis (Week 0 and 2)]
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Secondary Outcome(s)
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Change in LDL particle size between the two lipid apheresis treatment
[Time Frame: At the end of the two lipid apheresis (Week 0 and 2)]
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Change in plasma adhesion molecule levels between the two lipid apheresis treatment
[Time Frame: At the end of the two lipid apheresis (Week 0 and 2)]
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Change in plasma inflammatory marker levels between the two lipid apheresis treatment
[Time Frame: At the end of the two lipid apheresis (Week 0 and 2)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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