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โ† Trials
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REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults

RecruitingPhase 3Ages 18 Years - anyAllRegeneron Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: 1. Is undergoing a primary elective unilateral TKA 2. Is in good health based on laboratory safety testing as described in the protocol 3. Body weight โ‰ค130 kg at screening visit as described in the protocol Key Exclusion Criteria: 1. 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 2. History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion as described in the protocol 3. History of thromboembolic disease or thrombophilia 4. History of major surgery, including brain, spinal, or ocular, or major trauma within approximately the past 6 months prior to randomization 5. 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
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What it tests

  • REGN7508
  • Apixaban
  • Enoxaparin
  • Placebo
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Where

47 sites
Shoals Medical Trials, Inc.
Sheffield, United States
CARI Clinical Trials
Riverside, United States
Denver Metro Orthopedics, P.C. Englewood Location
Englewood, United States
Delray Physician Care Center
Delray Beach, United States
Bioresearch Partner
Miami, United States
Sacred Heart Health System Inc
Pensacola, United States
Gulfcoast Research Institute
Sarasota, United States
Phoenix Clinical Research
Tamarac, United States

โ€ฆand 39 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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