REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults

Официальное название

A Phase 3, Multicenter, Randomized, Open-Label, Study to Evaluate REGN7508, A Factor XI Monoclonal Antibody, Versus Apixaban and Enoxaparin for Prophylaxis of Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-APEX)

Обзор

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)

Вмешательства

• Препарат REGN7508
  Administered per the protocol
• Препарат Apixaban
  Administered per the protocol
• Препарат Enoxaparin
  Administered per the protocol
• Препарат Placebo
  Administered per the protocol

Первичные конечные точки

• Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death] [Срок оценки: Through day 12 visit, approximately 14 days]

Вторичные конечные точки (12)

• Time-to-first event of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death) [Срок оценки: Through day 12 visit, approximately 14 days]
• Incidence of confirmed symptomatic Deep Venous Thrombosis (DVT) [Срок оценки: Through day 12 visit, approximately 14 days]
• Incidence of confirmed Pulmonary Embolism (PE) [Срок оценки: Through day 12 visit, approximately 14 days]
• Incidence of VTE-related death [Срок оценки: Through day 12 visit, approximately 14 days]
• Time-to-first event of confirmed symptomatic DVT [Срок оценки: Through day 12 visit, approximately 14 days]
• Time-to-first event of confirmed PE [Срок оценки: Through day 12 visit, approximately 14 days]
• Time to VTE-related death [Срок оценки: Through day 12 visit, approximately 14 days]
• Incidence of the composite endpoint of major and Clinically Relevant Non-Major (CRNM) bleeding [Срок оценки: Through day 12 visit, approximately 14 days]
• Incidence of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death) [Срок оценки: Through day 12 visit, approximately 14 days]
• Incidence of minor bleeding [Срок оценки: Through day 12 visit, approximately 14 days]
• Incidence of Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Approximately day 90]
• Occurrence of Anti-Drug Antibodies (ADA) to REGN7508 [Срок оценки: Approximately day 90]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• Has an estimated Glomerular Filtration Rate (GFR) of <30 mL/min/1.73 m2 at the screening visit as described in the protocol

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 20 центров

• Shoals Medical Trials, Inc. — Sheffield
• CARI Clinical Trials — Riverside
• Denver Metro Orthopedics, P.C. Englewood Location — Englewood
• Delray Physician Care Center — Delray Beach
• Bioresearch Partner — Miami
• Sacred Heart Health System Inc — Pensacola
• Gulfcoast Research Institute — Sarasota
• Phoenix Clinical Research — Tamarac
• … и ещё 12 центров

Япония · 6 центров

• Kansai Rosai Hospital — Amagasaki-shi
• Yuuai Medical Center — Tomigusuku
• National Hospital Organization Osaka Minami Medical Center — Kawachi-Nagano
• Osaka Saiseikai Nakatsu Hospital — Kita-Ku
• Juntendo University Hospital — Bunkyo-ku
• Saga University Hospital — Saga

Латвия · 5 центров

• Liepajas regionala slimnica; SIA — Liepāja
• Rigas 2 slimnica, SIA — Riga
• Hospital of Traumatology and Orthopaedics — Riga
• ORTO Klinika — Riga
• Vidzemes slimnica — Valmiera

Венгрия · 4 центра

• Szegedi Tudomanyegyetem; Albert Szent-Gyorgyi Clinical Center — Szeged
• Gyor-Moson-Sopron Varmegyei Egyetemi Oktato Korhaz — Győr
• University of Debrecen — Debrecen
• Semmelweis University — Budapest

Болгария · 3 центра

• Multi-profile Hospital for Active Treatment Hearth and Brain EAD — Pleven
• Multiprofile Hospital for Active Treatment; Sveta Sofia EOOD (MBAL Sveta Sofia), — Sofia
• University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich" — Stara Zagora

Литва · 3 центра

• Lietuvos sveikatos mokslu universiteto Kauno ligonine — Kaunas
• Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik — Kaunas
• Vsi Klaipedos Universitetine Ligonine — Klaipėda

Польша · 3 центра

• Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. z o.o. — Krakow
• Uniwersytecki Szpital Kliniczny nr.2 Uniwersytetu Medycznego w Lodzi — Lodz
• Samodzieny Publiczny Zaklad Opieki Zdorowotne (SP ZOZ) Centralny Szpital Kliniczny Uniwers — Lodz

Румыния · 2 центра

• Arensia Clinics S.R.L — Bucharest
• ARENSIA Exploratory Medicine, County Hospital Cluj-Napoca — Cluj-Napoca

Идентификаторы

NCT: NCT07015905 · R7508-DVT-24116 · 2025-520478-20-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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