Calendario›REGN›REGN9933

REGN9933

A Trial to Learn How Well REGN9933 Works for Preventing Blood Clots After Knee Replacement Surgery in Adult Participants

Ensayo de REGENERON PHARMACEUTICALS, INC. en Venous Thromboembolism (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

373

previstos

Centros

16

Fin del objetivo primario

may 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en may 2023.

Qué mide

Percentage of Participants With Confirmed, Adjudicated Venous Thromboembolism (VTE) (REGN9933 vs Enoxaparin) (Through Day 12) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05618808), actualizada en ago 2025.