NCT07015905招募中3 期
A Phase 3, Multicenter, Randomized, Open-Label, 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)
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 66
- 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
This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery.
The aim of the study is to see how effective the study drug is at preventing Venous Thromboembolism (VTE) and other related diseases after total knee replacement surgery.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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
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
- •Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
研究组 & 干预措施
IV Placebo, SC REGN7508
Experimental
干预措施: REGN7508 (Drug)
IV Placebo, SC REGN7508
Experimental
干预措施: Placebo (Drug)
IV REGN7508
Experimental
干预措施: REGN7508 (Drug)
IV Placebo, apixaban
Active Comparator
干预措施: Apixaban (Drug)
IV Placebo, apixaban
Active Comparator
干预措施: Placebo (Drug)
IV Placebo, enoxaparin
Active Comparator
干预措施: Enoxaparin (Drug)
IV Placebo, enoxaparin
Active Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death]
时间窗: Through day 12 visit, approximately 14 days
次要结局
- Incidence of confirmed symptomatic Deep Venous Thrombosis (DVT)(Through day 12 visit, approximately 14 days)
- Incidence of confirmed Pulmonary Embolism (PE)(Through day 12 visit, approximately 14 days)
- Incidence of VTE-related death(Through day 12 visit, approximately 14 days)
- Incidence of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death)(Through day 12 visit, approximately 14 days)
- Incidence of minor bleeding(Through day 12 visit, approximately 14 days)
- Incidence of Treatment Emergent Adverse Events (TEAEs)(Approximately day 90)
- Concentrations of REGN7508(Approximately day 90)
- Time-to-first event of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death)(Through day 12 visit, approximately 14 days)
- Time-to-first event of confirmed symptomatic DVT(Through day 12 visit, approximately 14 days)
- Time-to-first event of confirmed PE(Through day 12 visit, approximately 14 days)
- Time to VTE-related death(Through day 12 visit, approximately 14 days)
- Incidence of the composite endpoint of major and Clinically Relevant Non-Major (CRNM) bleeding(Through day 12 visit, approximately 14 days)
- Occurrence of Anti-Drug Antibodies (ADA) to REGN7508(Approximately day 90)
- Magnitude of ADA to REGN7508(Approximately day 90)
研究者
研究点 (66)
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