2025-520478-20-00招募中3 期
A Phase 3, Multicenter, Randomized, Open-Label, Sponsor-Blinded, Study to Evaluate REGN7508, A Factor XI Monoclonal Antibody, Versus Apixaban and Enoxaparin for Prophylaxis of Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-APEX).
Regeneron Pharmaceuticals Inc.15 个研究点 分布在 5 个国家目标入组 1,067 人开始时间: 2025年10月8日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,067
- 试验地点
- 15
- 主要终点
- Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death].
研究概览
简要总结
To evaluate the efficacy of IV REGN7508 for the prevention of VTE after TKA compared to enoxaparin and apixaban.
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.
- •Body weight <130 kg at screening visit as described in the protocol.
- •Other protocol-defined Inclusion Criteria apply.
排除标准
- •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.
- •History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion as described in the protocol.
- •History of thromboembolic disease or thrombophilia.
- •History of major surgery, including brain, spinal, or ocular, or major trauma within approximately the past 6 months prior to randomization.
- •Has an estimated Glomerular Filtration Rate (GFR) of <30 mL/min/1.73 m2 at the screening visit as described in the protocol.
- •Other protocol-defined Exclusion Criteria apply.
结局指标
主要结局
Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death].
Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death].
次要结局
- Concentrations of REGN7508.
- Incidence of confirmed symptomatic Deep Venous Thrombosis (DVT).
- Incidence of confirmed Pulmonary Embolism (PE).
- Incidence of VTE-related death.
- Incidence of the composite endpoint of major and clinically relevant nonmajor (CRNM) bleeding.
- Incidence of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death).
- Incidence of minor bleeding.
- Incidence of Treatment Emergent Adverse Events (TEAEs).
- Incidence of Anti-Drug Antibodies (ADA) to REGN7508.
- Titer of ADA to REGN7508.
研究者
Medical Affairs
Scientific
Regeneron Pharmaceuticals Inc.
研究点 (15)
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