NCT03135184

HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: HDL Therapeutics · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Homozygous Familial Hypercholesterolemia
• HoFH

Interventions

Type	Name	Description
DEVICE	HDL Therapeutics PDS-2 System	Delipidation of plasma HDL to reduce coronary atheroma

Timeline

• Start date: 2018-01-26
• Primary completion: 2019-01-07
• Completion: 2019-08-01
• First posted: 2017-05-01
• Last updated: 2019-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study