An Open, Randomized, Active-comparator-controlled, Multicenter Study to Assess the Efficacy and Safety of Different Doses of KN060 for the Prevention of Venous Thromboembolism in Patients Undergoing Unilateral Total Knee Arthroplasty.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral venography, objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded
研究概览
简要总结
This study was to compare the study drug KN060 to enoxaparin, for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA).
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged between 18 and 75 years old (including the cut-off value);
- •undergoing unilateral Total Knee Arthroplasty (TKA);
- •Voluntarily participate in the study and sign a written informed consent;
排除标准
- •There is a high risk of bleeding or abnormal bleeding related indicators:
- •Evidence of venous thrombosis, such as the presence of related symptoms or auxiliary tests indicating thrombosis; Or have a history of venous embolic disease.
- •Acute myocardial infarction or ischemic stroke occurred within 6 months before screening.
- •Presence of malignant tumors or history of malignant tumors.
研究组 & 干预措施
Enoxaparin
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days post-surgery.
干预措施: Enoxaparin (Drug)
KN060 Low (post-surgery)
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 low dose once post-surgery.
干预措施: KN060 Low (Drug)
KN060 Middle (post-surgery)
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 middle dose once post-surgery.
干预措施: KN060 Middle (Drug)
KN060 Hight (post-surgery)
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 hight dose once post-surgery.
干预措施: KN060 Hight (Drug)
结局指标
主要结局
Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral venography, objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded
时间窗: Up to 14 days
DVT - Deep vein thrombosis / PE - Pulmonary embolism. All suspected events were reviewed and classified by the investigator
次要结局
- Incidence of unexplained death for which PE cannot be excluded(Up to 14 \35\100 days)
- Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral venography, objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded(Up to 35\100 days)
- Incidence of clinically relevant non-major bleeding(Up to 14 \35\100 days)
- Incidence of fatal PE(Up to 14 \35\100 days)
- Incidence of treatment emergent adverse event/adverse drug reaction(Up to 14 \35\100 days)
- Pharmacodynamics index: Changes of plasma concentration of Free FⅪ from baseline;(Up to 100 days)
- Incidence of symptomatic DVT, non-fatal PE(Up to 14 \35\100 days)
- Incidence of major bleeding(Up to 14 \35\100 days)
- Incidence of composite endpoint of major and clinically relevant non-major bleeding(Up to 35\100 days)
- Incidence of bleeding(Up to 14 \35\100 days)
- Plasma Concentration of KN060(Up to 100 days)
- Pharmacodynamics index: Changes of APTT from baseline;(Up to 100 days)
- Pharmacodynamics index: Changes of FⅪ activity from baseline;(Up to 100 days)