NCT05752461已完成2 期
A Multicenter, Randomized, Active-comparator-controlled Phase 2 Clinical Trial to Assess the Efficacy and Safety of a Single Subcutaneous Injection of SHR-2004 in Patients Undergoing Elective Unilateral Total Knee Arthroplasty
Beijing Suncadia Pharmaceuticals Co., Ltd1 个研究点 分布在 1 个国家目标入组 353 人开始时间: 2023年4月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 353
- 试验地点
- 1
- 主要终点
- Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral CT venography, confirmed symptomatic DVT, non-fatal PE and all-cause death（Primary efficacy outcome）
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of SHR-2004 in preventing venous thromboembolism after elective unilateral total knee arthroplasty
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand the research procedures and methods, volunteer to participate in the study, and sign the informed consent
- •Scheduled to undergo elective unilateral total knee arthroplayts (TKA)
- •Male or female(≥ 40 years old and < 80 years old)
排除标准
- •Unable to receive CT angiography of both lower limbs;
- •Malignant tumor within one year of the screening ;
- •History of venous thromboembolism;
- •Myocardial infarction, transient ischemic attack or ischemic stroke occurred within 6 months of the screening;
- •Any medical history that may increase the risk of bleeding or any conditions that the investigator considers to increase the risk of bleeding
- •Any of the laboratory test indicators meets the following criteria:
- •①estimated Glomerular Filtration Rate < 60 mL/min/1.73m2 ;
- •②Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal value (ULN);
- •③total bilirubin was > 2 times, etc
- •History of drug abuse;
- •Pregnant or lactating women
研究组 & 干预措施
Treatment group A: SHR-2004 injection
Experimental
干预措施: SHR-2004 injection (Drug)
Treatment group B: SHR-2004 injection
Experimental
干预措施: SHR-2004 injection (Drug)
Treatment group C: SHR-2004 injection
Experimental
干预措施: SHR-2004 injection (Drug)
Treatment group D: Enoxaparin sodium injection
Active Comparator
干预措施: Enoxaparin sodium injection (Drug)
结局指标
主要结局
Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral CT venography, confirmed symptomatic DVT, non-fatal PE and all-cause death（Primary efficacy outcome）
时间窗: Day 12
Incidence of composite endpoint of major and clinically relevant non-major bleeding（Primary safety outcome）
时间窗: Day 12
次要结局
- Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral CT venography, confirmed symptomatic DVT, non-fatal PE and all-cause death（Secondary efficacy endpoint）(Day 85)
- Incidence of composite endpoint of any bleeding（Secondary safety endpoint）(Day 12)
- Incidence of composite endpoint of major and clinically relevant non-major bleeding（Secondary safety endpoint）(Day 85)
研究者
研究点 (1)
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