HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia
Overview
Assess the effect on coronary atheroma of serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics PDS-2™ System
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: January 7, 2019
Detailed Description
The PDS-2™ System is intended to reduce coronary atheroma in patients with Homozygous Familial Hypercholesterolemia (HoFH). Subjects will receive serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics' PDS-2 System.
Interventions
- Device: HDL Therapeutics PDS-2 System
- Delipidation of plasma HDL to reduce coronary atheroma
Arms, Groups and Cohorts
- Experimental: HDL Therapeutics PDS-2™ System
- Serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics PDS-2™ System
Clinical Trial Outcome Measures
Primary Measures
- Change in coronary atheroma
- Time Frame: 2 months
- Assessed by coronary imaging in study coronary artery segments following serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics PDS-2™ System as compared to baseline
Participating in This Clinical Trial
Key Inclusion Criteria:
- Clinical diagnosis of Homozygous Familial Hypercholesterolemia (HoFH) due to a defect in the LDL receptor, or the identification of a defect in apoB-100, or a gain of function of PCSK9, or a genetic defect resulting in the HoFH clinical phenotype – 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. Key Exclusion Criteria:
- Planned change in current lipid lowering therapy – 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
Gender Eligibility: All
Minimum Age: 12 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- HDL Therapeutics
- Collaborator
- MedStar Heart and Vascular Institute
- Provider of Information About this Clinical Study
- Sponsor
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