HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia
NCT ID: NCT03135184
Last Updated: 2019-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
6 participants
INTERVENTIONAL
2018-01-26
2019-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HDL Therapeutics PDS-2™ System
Serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics PDS-2™ System
HDL Therapeutics PDS-2 System
Delipidation of plasma HDL to reduce coronary atheroma
Interventions
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HDL Therapeutics PDS-2 System
Delipidation of plasma HDL to reduce coronary atheroma
Eligibility Criteria
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Inclusion Criteria
* No other condition that would preclude the subject from successfully completing the series of plasmapheresis visits in the investigator's opinion
* At least one (1) coronary artery study segment will be identified for each subject and all will remain constant throughout the study. The qualifying study segment(s) will have 20% to 40% stenosis.
Exclusion Criteria
* Use of oral anticoagulants, unless the dose has been stable for 4 weeks
* LDL or plasma apheresis within 1 week prior to enrollment and through 8-week primary endpoint
* New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction \< 30%
* Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months of enrollment
12 Years
ALL
No
Sponsors
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MedStar Heart and Vascular Institute
UNKNOWN
HDL Therapeutics
INDUSTRY
Responsible Party
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Locations
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Cedars-Sinai Medical Center (CSMC)
Los Angeles, California, United States
Countries
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Other Identifiers
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HALO-FH
Identifier Type: -
Identifier Source: org_study_id
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