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)
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
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
Parallel
REGN7508
DrugAdministered per the protocol
Apixaban
DrugAdministered per the protocol
Enoxaparin
DrugAdministered per the protocol
Placebo
DrugAdministered per the protocol
Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death]
Time-to-first event of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death)
Incidence of confirmed symptomatic Deep Venous Thrombosis (DVT)
Incidence of confirmed Pulmonary Embolism (PE)
Incidence of VTE-related death
Click on the lead sponsor to view all of their trials.
