HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia



Status:Recruiting
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:12 - Any
Updated:2/24/2019
Start Date:January 26, 2018
End Date:June 2019
Contact:Bryan Brewer, MD
Email:Bryan.Brewer@MedStar.net
Phone:202-877-0188

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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

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.

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
We found this trial at
1
site
8700 Beverly Boulevard
Los Angeles, California 90048
Phone: 310-423-3884
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Los Angeles, CA
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