A Phase 2, Randomized, Active Comparator-Controlled, Open-Label, Adaptive Design Study to Assess the Safety and Efficacy of Intravenously-Administered SelK2 in Patients Undergoing Total Knee Arthroplasty
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 21
- 主要终点
- Percentage of Participants With Total Venous Thromboembolism
研究概览
简要总结
The main purpose of this study is to determine if an investigational medication called SelK2 works in preventing a condition called "venous thromboembolism" (VTE) in patients having a total knee replacement. SelK2 has been designed to attach to a protein found on blood cells and blood vessels. By attaching to this protein, SelK2 is designed to decrease the inflammatory process in the blood vessel wall that leads to the formation of blood clots in the vessel (called thrombosis). By decreasing the inflammatory process, SelK2 may reduce the risk of VTE following joint replacement surgery. In addition, because SelK2 is not a blood thinner, it is expected that the risk for bleeding will also be reduced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, 18-80 years of age (inclusive)
- •Planned to undergo elective, primary total unilateral Total Knee Arthroplasty under general anesthesia
排除标准
- •Previous deep vein thrombosis (DVT) of the leg or pulmonary embolism (PE) within the past year
- •Any underlying condition (e.g., atrial fibrillation, mechanical heart valve, or recent pulmonary embolism) that may lead to the required concomitant use of anticoagulants/antiplatelet agents (e.g., warfarin, dabigatran, rivaroxaban, apixaban, clopidogrel) that may affect study outcome or any other drug influencing coagulation (except low dose aspirin (100 mg or less))
- •Anticipated use of intermittent pneumatic compression devices and/or electrical/mechanical muscle stimulators post Total Knee Arthroplasty procedure
研究组 & 干预措施
SelK2 and Enoxaparin
I.V., single-dose (SelK2) and SC, QD for up to 10 ± 2 days (Enoxaparin)
干预措施: SelK2 (Drug)
SelK2 and Enoxaparin
I.V., single-dose (SelK2) and SC, QD for up to 10 ± 2 days (Enoxaparin)
干预措施: Enoxaparin (Biological)
Enoxaparin
SC, QD for up to 10 ± 2 days
干预措施: Enoxaparin (Biological)
SelK2
I.V., single-dose
干预措施: SelK2 (Drug)
结局指标
主要结局
Percentage of Participants With Total Venous Thromboembolism
时间窗: 10 ± 2 Days After Total Knee Replacement
The primary efficacy endpoint was incidence of total VTE (reported as a percentage of patients) during the Treatment Phase up to venography day (10 ± 2 days after total knee replacement). All efficacy endpoint data was adjudicated by the blinded Central Independent Adjudication Committee (CIAC).
Percentage of Participants With Major or Clinically Relevant Non-major Bleeding Events
时间窗: 10 ± 2 Days After Total Knee Replacement
All suspected bleeding events were reviewed by the Central Independent Adjudication Committee (CIAC) in a blinded fashion and were adjudicated for categorization as Major Bleeding (MB), Clinically Relevant Non-Major Bleeding (CRNMB), Minor Bleeding, or combination of MB and CRNMB. The outcome measure assessed the incidence of MB or CRNMB.
次要结局
未报告次要终点