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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