Clinical Trial: HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia

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 Summary: 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.
Sponsor: HDL Therapeutics

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: HDL Therapeutics

Dates:
Date Received: April 26, 2017
Date Started: June 2017
Date Completion: June 2019
Last Updated: April 26, 2017
Last Verified: April 2017