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

NCT07213778

RecruitingPhase 3

Sponsor: Regeneron Pharmaceuticals

Conditions: Symptomatic Venous Thromboembolism (VTE)

Interventions: REGN7508, Acetylsalicylic Acid (ASA), Placebo

Countries: United States, Greece, Malaysia, Moldova

This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called Acetylsalicylic Acid (ASA). 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)

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

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
Locations (34)
  • La Mesa, California, United States
  • Rancho Mirage, California, United States
  • Lone Tree, Colorado, United States
  • Deerfield Beach, Florida, United States
  • Miami, Florida, United States
  • South Miami, Florida, United States
  • Tamarac, Florida, United States
  • Skokie, Illinois, United States
  • Indianapolis, Indiana, United States
  • Wichita, Kansas, United States
  • Annapolis, Maryland, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Teaneck, New Jersey, United States
  • Rochester, New York, United States
  • Raleigh, North Carolina, United States
  • Raleigh, North Carolina, United States
  • Wilmington, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Columbus, Ohio, United States
  • Columbus, Ohio, United States
  • Pittsburgh, Pennsylvania, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • San Antonio, Texas, United States
  • San Antonio, Texas, United States
  • Roanoke, Virginia, United States
  • Spokane, Washington, United States
  • Athens, Attica, Greece
  • + 4 more on CT.gov