EUCTR2016-004550-15-PL进行中（未招募）1 期
A Randomized, Double-blind, Double-dummy, Multicenter, Adaptive Design Dose-Escalation (Part 1) and Dose-Response (Part 2) Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female of non-childbearing potential
- •- At least 50 years of age or older
- •- Weight 40 kg to 150 kg
- •- Medically appropriate for postoperative anticoagulant prophylaxis
- •- Has undergone an elective primary unilateral TKR
- •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 1000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 500
排除标准
- •- Any condition for which the use of apixaban is not recommended in the opinion of the investigator
- •- Bilateral, revision or unicompartmental procedure
- •- Known or suspected hypersensitivity or intolerance to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or any of the excipients of JNJ-64179375
- •- Unable to undergo venography
- •- Known previous DVT in either lower extremity
- •- Any preplanned invasive procedure (eg, surgery, colonoscopy) up to Week 18 for which anticoagulant or antiplatelet therapy would be interrupted
- •- Planned use of intermittent pneumatic compression after randomization
研究者
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