2022-501470-18-00已完成2 期
A Phase 2, Multicenter, Randomized, Open-Label, Active-Control Study of REGN9933, a Factor XI Monoclonal Antibody, for Prevention of Venous Thromboembolism after Elective, Unilateral, Total Knee Arthroplasty
Regeneron Pharmaceuticals Inc.16 个研究点 分布在 6 个国家目标入组 408 人开始时间: 2023年4月6日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 408
- 试验地点
- 16
- 主要终点
- The primary endpoint is the incidence of confirmed, adjudicated venous thromboembolism (VTE) through day 12 (REGN9933 vs enoxaparin).
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of REGN9933 for the prevention of venous thromboembolism (VTE) after unilateral total knee arthroplasty (TKA), compared to enoxaparin.
研究设计
- 分配方式
- Randomized
- 主要目的
- Method of treatment assignment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Undergoing elective unilateral TKA
- •Has a body weight ≤130 kg at screening visit
- •Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and Electrocardiograms (ECG) performed at screening and/or prior to administration of initial dose of study drug
- •Is in good health based on laboratory safety testing obtained during the screening period as described in the protocol
- •Other protocol-defined inclusion criteria apply
排除标准
- •History of bleeding in the past 6 months 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.
- •History of thromboembolic disease or thrombophilia.
- •History of major surgery, including brain, spinal, or ocular, within approximately the past 6 months.
- •History of major trauma within approximately the past 6 months.
- •Hospitalized (>24 hours) for any reason within 30 days of the screening visit.
- •Using the Modification of Diet in Renal Disease equation, has an estimated glomerular filtration rate as described in the protocol.
- •Other protocol-defined exclusion criteria apply.
结局指标
主要结局
The primary endpoint is the incidence of confirmed, adjudicated venous thromboembolism (VTE) through day 12 (REGN9933 vs enoxaparin).
The primary endpoint is the incidence of confirmed, adjudicated venous thromboembolism (VTE) through day 12 (REGN9933 vs enoxaparin).
次要结局
- Incidence of major bleeding (up to approximately day 12).
- Incidence of clinically relevant non-major (CRNM) bleeding (up to approximately day 12).
- Incidence of treatment emergent adverse events (TEAEs) (through end of study; approximately day 75).
- Incidence of major VTE through day 12 (REGN9933 versus enoxaparin).
- Incidence of DVT as measured by venography of the operated leg (approximately day 12; REGN9933 vs enoxaparin).
- Concentrations of REGN9933 in serum (through end of study; approximately day 75).
- Change in activated partial thromboplastin time (aPTT) from baseline (through end of study; approximately day 75).
- Change in prothrombin time (PT) from baseline (through end of study; approximately day 75).
- Incidence of anti-drug antibodies (ADA) to REGN9933 (through end of study; approximately day 75).
- Titer of anti-drug antibodies (ADA) to REGN9933 (through end of study; approximately day 75).
- Incidence of confirmed, adjudicated VTE (baseline through day 12; enoxaparin vs apixaban).
研究者
Medical Affairs
Scientific
Regeneron Pharmaceuticals Inc.
研究点 (16)
Loading locations...
相似试验
招募中
2 期
A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC)Venous Thromboembolism2023-508603-21-00Regeneron Pharmaceuticals Inc.93
招募中
3 期
REGN7508 versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults.2025-520478-20-00Regeneron Pharmaceuticals Inc.1,067
招募中
3 期
Phase 3 study of VGA039 prophylaxis in adolescent and adult patients with von Willebrand Disease2025-522056-10-01Vega Therapeutics Inc.2
已完成
1 期
A trial to learn if REGN7999 is safe and well tolerated, and how it works in the body of healthy participants.2022-500398-15-00Regeneron Pharmaceuticals Inc., Regeneron Pharmaceuticals Inc.64
招募中
3 期
An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants with Active Thyroid Eye Disease (TED)Thyroid eye disease2024-514972-42-00Viridian Therapeutics S.à.r.l.45