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 - R9933-DVT-2230

Regeneron Pharmaceuticals Inc.0 个研究点目标入组 432 人开始时间: 2022年12月12日最近更新: 2024年7月22日

研究概览

暂无简介。

•1. Undergoing elective unilateral TKA, 2. Has a body weight =130 kg at screening visit, 3. 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, 4. 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

•1. 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., 2. History of thromboembolic disease or thrombophilia., 3. History of major surgery, including brain, spinal, or ocular, within approximately the past 6 months., 4. History of major trauma within approximately the past 6 months., 5. Hospitalized (>24 hours) for any reason within 30 days of the screening visit., 6. 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.

发起方

Regeneron Pharmaceuticals Inc.