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Recruiting Phase 3 NCT07213778

REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants

Phase 3 – large-scale trial before approval
Conditions: Symptomatic Venous Thromboembolism (VTE)

Sponsor: Regeneron Pharmaceuticals

trial.available_in: БГ
Overview
This study is researching an experimental drug called REGN7508 versus Acetylsalicylic Acid (ASA) (each 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 compared to acetylsalicylic acid. 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)
Who can participate
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 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; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis (eg, hemophilia A or B, von Willebrand's Factor deficiency) 3. History of thromboembolic disease or thrombophilia 4. History of platelet dysfunction 5. Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Interventions
REGN7508
DRUG
Acetylsalicylic Acid (ASA)
DRUG
Placebo
DRUG
Locations 14
United States (14)
Sinai Hospital of Baltimore, Inc.
Baltimore , Maryland
University of Cincinnati
Cincinnati , Ohio
Ohio Clinical Trials
Columbus , Ohio
HD Research - Memorial Hermann Village
Houston , Texas
Sky Ridge Medical Center
Lone Tree , Colorado
Medical Research of Westchester - MPLUS Research Network
Miami , Florida
Eisenhower Medical Center
Rancho Mirage , California
Endeavor Clinical Trials
San Antonio , Texas
Endeavor Health
Skokie , Illinois
Spokane Joint Replacement Center
Spokane , Washington
Phoenix Clinical Research
Tamarac , Florida
Holy Name Medical Center
Teaneck , New Jersey
NextStage Clinical Research, St. Francis Medical Park
Wichita , Kansas
Coastal Vascular Institute, PA
Wilmington , North Carolina
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
24.11.2025
Completion date
16.07.2027
Registry ID
NCT07213778
Source
clinicaltrials.gov
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