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A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants
Sponsor: Regeneron Pharmaceuticals
Summary
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 (TKR) 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 unilateral 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 drug less effective or could lead to side effects)
Official title: A Phase 2, Multicenter, Randomized, Open-Label, Active Control Study of REGN7508, a Factor XI Monoclonal Antibody, for Prevention of Venous Thromboembolism After Elective, Unilateral, Total Knee Arthroplasty (ROXI-VTE II)
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
179
Start Date
2024-06-27
Completion Date
2025-01-21
Last Updated
2026-05-27
Healthy Volunteers
No
Conditions
Interventions
REGN7508
Administered by single intravenous (IV) dose
Enoxaparin
Administered by subcutaneous (SC) dose daily through the time of venography (or day 12, whichever is earlier)
Locations (14)
Multi-profile Hospital for Active Treatment Hearth and Brain EAD
Pleven, Bulgaria
Multiprofile Hospital For Active Treatment Park Hospital Ltd.
Plovdiv, Bulgaria
Budai Irgalmasrendi Korhaz
Budapest, Hungary
Szolnoki MAV Hospital
Szolnok, Hungary
Vidzemes Hospital
Valmiera, Valmieras Aprinkis, Latvia
Liepaja Regional Hospital
Liepāja, Latvia
Riga's 2nd Hospital
Riga, Latvia
Hospital of Traumatology and Orthopaedics
Riga, Latvia
Orto Klinika
Riga, Latvia
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik
Kaunas, Kaunas County, Lithuania
Lithuanian University of Health Sciences Kaunas Hospital
Kaunas, Lithuania
Klaipeda University Hospital
Klaipėda, Lithuania
Specjalistyczny Szpital im. E. Szczeklika w Tarnowie
Tarnów, Lesser Poland Voivodeship, Poland
Clinic of Orthopaedics and Paediatric Orthopaedics
Lodz, Łódź Voivodeship, Poland