NCT03393481撤回2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Number of patients with confirmed composite endpoint
研究概览
简要总结
The purpose of the study is to find out whether MAA868, is able to prevent blood clots following your medical condition (surgery for knee replacement)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Open-label, blinded endpoint assessment
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
- •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
排除标准
- •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
研究组 & 干预措施
MAA868 dose 1
Experimental
MAA868 dose 1, single administration, subcutaneous
干预措施: MAA868 (Drug)
MAA868 dose 2
Experimental
MAA868 dose 2, single administration, subcutaneous
干预措施: MAA868 (Drug)
Enoxaparin
Active Comparator
Enoxaparin 40mg, once daily (o.d.) for 10 days
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Number of patients with confirmed composite endpoint
时间窗: Day 14
Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death
次要结局
- Number of patients with composite venous thromboembolic events (VTE)(Day 1 to Day 110)
- Number of patients with composite bleeding(Day 1 to Day 50)
研究者
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