HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in coronary atheroma
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
HDL Therapeutics PDS-2™ System
Serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics PDS-2™ System
干预措施: HDL Therapeutics PDS-2 System (Device)
结局指标
主要结局
Change in coronary atheroma
时间窗: 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
次要结局
未报告次要终点