Status:
RECRUITING
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Symptomatic Venous Thromboembolism (VTE)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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) t...
Eligibility Criteria
Inclusion
- Key
- Is undergoing a primary elective unilateral TKA
- Is in good health based on laboratory safety testing as described in the protocol
- Key
Exclusion
- 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
- 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)
- History of thromboembolic disease or thrombophilia
- History of platelet dysfunction
- Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery
- Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Key Trial Info
Start Date :
November 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 16 2027
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT07213778
Start Date
November 24 2025
End Date
July 16 2027
Last Update
December 19 2025
Active Locations (2)
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1
Phoenix Clinical Research
Tamarac, Florida, United States, 33321
2
HD Research - Memorial Hermann Village
Houston, Texas, United States, 77043