Venous Thromboembolism Clinical Trial
Official title:
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
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 The secondary objectives of the study are: - To evaluate the bleeding risk (ie, major and clinically relevant non-major [CRNM] bleeding) of REGN9933 after unilateral TKA through time of venography, compared to enoxaparin - To assess overall safety and tolerability of REGN9933 in participants undergoing TKA - To evaluate the efficacy of REGN9933 in prevention of clinically relevant VTE, compared to enoxaparin - To evaluate the efficacy of REGN9933 in prevention of deep venous thrombosis (DVT) detected by venography, compared to enoxaparin - To evaluate the pharmacokinetics (PK) of REGN9933 after single intravenous (IV) administration - To assess pharmacodynamic (PD) effects of REGN9933 on intrinsic and extrinsic coagulation pathways - To assess immunogenicity following a single dose of REGN9933 over time - To compare the efficacy of enoxaparin and apixaban in prevention of VTE after unilateral TKA
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