A multicenter, randomized, open-label, blinded endpoint evaluation, active-controlled Phase 2 study to compare the efficacy and safety of s.c. MAA868 versus s.c. enoxaparin in adult patients undergoing unilateral total knee arthroplasty

ovartis Pharma AG0 个研究点目标入组 600 人开始时间: 2018年2月22日最近更新: 2018年8月20日

适应症

试验速览

暂无简介。

•- Scheduled to undergo elective unilateral total knee arthroplayts (TKA).
•- Willing to comply with study requirements including bilateral venography at Day 12 ± 2 days.
•- Body weight between 50 kg and 130 kg inclusive.
•- Normal aPTT, PT, INR at screening.
•- See full list in protocol.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 450

•- History of arterial or venous thromboembolism;
•- abnormally extended primary or secondary bleeding after trauma or intervention, stroke, transient ischemic attack or traumatic or non-traumatic intracranial bleed;
•- bleeding disorder;
•- MI or unstable angina pectoris within 12 months of the screening;
•- Uncontrolled hypertension (SBP/DBP = 150/95 mmHg at the screening).
•- Medications that increase the risk of bleeding, including antiplatelet (such as aspirin), anticoagulant and fibrinolytic agents;
•- eGFR <60 mL/min/1.73m2;
•- Poorly controlled diabetes (HbA1C >10%);
•- Liver dysfunction (ALT/AST >3 xULN or TBL >2 x ULN);
•- BMI = 40 kg/m2.
•- See full list in protocol.

发起方