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Recruiting
NCT07015905
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Conditions: Venous Thromboembolism (VTE)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 2000
Sponsor: Regeneron Pharmaceuticals
Location: Shoals Medical Trials, Inc. Sheffield Alabama
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 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)
Eligibility Criteria
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 ≤130 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 \
Source: ClinicalTrials.gov (NCT07015905). StuddyBuddy aggregates publicly available trial information.