MedPath

HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia

Not Applicable
Conditions
HoFH
Homozygous Familial Hypercholesterolemia
Registration Number
NCT03135184
Lead Sponsor
HDL Therapeutics
Brief Summary

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

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
6
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Change in coronary atheroma2 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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Cedars-Sinai Medical Center (CSMC)

🇺🇸

Los Angeles, California, United States

Cedars-Sinai Medical Center (CSMC)
🇺🇸Los Angeles, California, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.