2025-520479-25-00招募中3 期
A Phase 3, Multicenter, Double-Blinded, Randomized Study to Evaluate REGN7508, a Factor XI Monoclonal Antibody, Versus Acetylsalicylic Acid for Prophylaxis of Symptomatic Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-ASPEN)
Regeneron Pharmaceuticals Inc.11 个研究点 分布在 3 个国家目标入组 208 人开始时间: 2025年12月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 208
- 试验地点
- 11
- 主要终点
- Incidence of the composite endpoint of symptomatic VTE and VTE-related death
研究概览
简要总结
To evaluate the efficacy of IV REGN7508 for the prevention of symptomatic VTE after TKA compared to ASA
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Is undergoing a primary elective unilateral TKA.
- •Is in good health based on laboratory safety testing as described in the protocol
- •Other protocol-defined Inclusion criteria apply
排除标准
- •Has any condition that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant by study participation.
- •Has a history of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis (eg, hemophilia A or B, von Willebrand’s Factor deficiency).
- •Has a history of thromboembolic disease or thrombophilia.
- •Has a history of platelet dysfunction.
- •Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery
- •Other protocol-defined Exclusion criteria apply
研究组 & 干预措施
REGN7508
Test
干预措施: REGN7508 (Drug)
Placebo for REGN7508
Placebo
干预措施: Placebo for REGN7508 (Drug)
Placebo for Acetylsalicylic Acid
Placebo
干预措施: Placebo for Acetylsalicylic Acid (Drug)
ACETYLSALICYLIC ACID
Comparator
干预措施: ACETYLSALICYLIC ACID (Drug)
结局指标
主要结局
Incidence of the composite endpoint of symptomatic VTE and VTE-related death
Incidence of the composite endpoint of symptomatic VTE and VTE-related death
次要结局
- Incidence of confirmed symptomatic Deep Vein Thrombosis (DVT)
- Incidence of confirmed Pulmonary Embolism (PE)
- Incidence of VTE-related death
- Time to first event of the composite endpoint of symptomatic VTE and VTE-related death
- Time to first event of confirmed symptomatic DVT
- Time to first event of confirmed PE
- Time to VTE-related death
- Incidence of the composite endpoint of major bleeding and Clinically Relevant Non-Major (CRNM) bleeding
- Incidence of minor bleeding
- Incidence of Treatment-Emergent Adverse Events (TEAEs)
- Severity of TEAEs
- Incidence of Anti-drug Antibody (ADA) to REGN7508
- Magnitude of ADA to REGN7508
- Concentrations of REGN7508
研究者
Medical Affairs
Scientific
Regeneron Pharmaceuticals Inc.
研究点 (11)
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