[Translation] A randomized, open-label, positive-controlled, multicenter study to evaluate the efficacy and safety of different doses of KN060 in preventing venous thromboembolism in patients undergoing unilateral total knee replacement
主要目的:在行择期、首次、单侧全膝关节置换术(TKA)的患者中,评估不同剂量KN060对比依诺肝素钠注射液(依诺肝素)预防静脉血栓栓塞(VTE)的有效性。
次要目的:在行择期、首次、单侧TKA的患者中,评估:不同剂量KN060对比依诺肝素的安全性;单次静脉滴注KN060的药代动力学及药效学特点;KN060预防TKA术后VTE的剂量-效应关系。
[Translation] Primary objective: To evaluate the effectiveness of different doses of KN060 compared with enoxaparin sodium injection (enoxaparin) in preventing venous thromboembolism (VTE) in patients undergoing elective, first, unilateral total knee arthroplasty (TKA).
Secondary objective: To evaluate the safety of different doses of KN060 compared with enoxaparin in patients undergoing elective, first, unilateral TKA; the pharmacokinetic and pharmacodynamic characteristics of a single intravenous infusion of KN060; and the dose-effect relationship of KN060 in preventing VTE after TKA.