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COMPLETED
NCT06454630
PHASE2

A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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

Interventions

DRUG

REGN7508

Administered by single intravenous (IV) dose

DRUG

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