EXPLORATORY STUDY OF PLAQUE REGRESSION:A Phase II Single Center Open-Label Exploratory Trial of the Effect of CER 001 in Subjects With Familial Hypercholesterolemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Total Plaque Volume
研究概览
简要总结
Despite the availability of several classes of very effective drugs available to treat heterozygous Familial Hypercholesterolemia (HeFH), there remains a large unmet medical need for new, effective and well tolerated therapies. There are a number of therapies given on a chronic basis to reduce long term risk, such as statins, fibrates, niacin, omega 3 fatty acids, resins, cholesterol absorption inhibitors and antiplatelet or anticoagulant drugs, but subjects with heterozygous Familial Hypercholesterolemia remain at high risk for cardiovascular events. There is still a need for acute therapies that can lead to rapid pacification of unstable plaque in order to reduce the risk of these events. This study will assess the effects of CER-001 , a recombinant human Apo-A-1 based HDL mimetic, on indices of atherosclerotic plaque progression and regression as assessed by 3Tesla MRI (3TMRI)and intravascular ultrasound (IVUS) evaluations in patients with HeFH.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female subjects at least 18 years old
- •Subject presents heterozygous FH, known CHD and receiving maximally tolerated lipid modifying therapy, at stable doses for at least 3 months
- •LDL-C of > 110 mg/dl
- •Angiographic evidence of coronary artery disease with suitable "target" coronary artery for IVUS
排除标准
- •Confirmed diagnosis of homozygous FH
- •Significant health problems (other than cardiovascular disease) in the recent past including blood disorders, cancer, or digestive problems
- •Female subjects not meeting the study definition of non child-bearing potential
- •Use of an investigational agent within 30 days of the first CER-001 dose
- •Receiving current lipid apheresis
研究组 & 干预措施
Open label single arm study of CER-001
Open label single arm study of CER-001
干预措施: CER-001 (Drug)
结局指标
主要结局
Change in Total Plaque Volume
时间窗: Baseline and 3 weeks post final dose
Nominal change in total plaque volume (ACTPV), as assessed by 3D IVUS, from the baseline measurement to the follow-up taken \~3 weeks following the final dose of study medication (approximately 10 weeks after the baseline assessment)
次要结局
- Percent Change in Plaque Volume(Baseline and 3 weeks post final dose)
- Change in carotid plaque volume(Baseline and 3 weeks post final dose)