Phase II Open Label,Randomized Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of an Anti-Inflammatory Therapeutic Antibody(CV-18C3)in Reducing Restenosis in Patients Undergoing Percutaneous Femoro-popliteal Revascularization.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 8
- 主要终点
- Safety and tolerability of CV-18C3
研究概览
简要总结
The purpose of this study is to determine if CV-18C3 will reduce the rate of restenosis or the time to restenosis in patients undergoing repeat peripheral artery revascularization versus controls randomized to standard of care.
详细描述
Restenosis of peripheral artery lesions remains a challenging problem to overcome after percutaneous revascularization of atherosclerotic disease in the femoropopliteal arterial system. Rates of restenosis are as high as 60% after a year. Treatment options include medical therapy, angioplasty, arthrectomy and stent placement. The heterogeneity of disease between patients, variable length of target lesions and presence of unpredictable physical forces requires individualized treatment plans.
Vascular response to injury appears to play an important role in the development of restenosis. IL-1α is a potent inflammatory cytokine that plays a central role in vascular inflammation and vascular smooth muscle proliferation--both in acute and chronic injury. CV-18C3 antagonizes the biologic activity of IL-1α and is theorized to prevent the early IL-1α mediated inflammation that leads to vascular smooth muscle hypertrophy and restenosis, as well as the late IL-1α mediated atherosclerotic plaque formation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Have suspected superficial femoro-popliteal artery occlusion due to lower extremity pain with exercise or at rest and are undergoing a planned arteriogram.
- •Subjects will be randomized after angiographic evidence of qualifying lesion
排除标准
- •Acute critical limb ischemia
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- •Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
研究组 & 干预措施
CV-18C3 and standard of care
CV-18C3 and standard of care
干预措施: CV-18C3 (Drug)
CV-18C3 and standard of care
CV-18C3 and standard of care
干预措施: Standard of Care (Procedure)
standard of care
Percutaneous revascularization
干预措施: Standard of Care (Procedure)
结局指标
主要结局
Safety and tolerability of CV-18C3
时间窗: 1 year
adverse events, vitals signs, physical examination results and clinical laboratory values
次要结局
- Time to restenosis and restenosis rates compared between CV-18C3 and controls(1 year)