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REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults

NCT07015905

RecruitingPhase 3

Sponsor: Regeneron Pharmaceuticals

Conditions: Venous Thromboembolism (VTE)

Interventions: REGN7508, Apixaban, Enoxaparin, Placebo

Countries: United States, Bulgaria, Hungary, Japan, Latvia, Lithuania, Poland, Romania

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 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
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 \<30 mL/min/1.73 m2 at the screening visit as described in the protocol

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Locations (46)
  • Sheffield, Alabama, United States
  • Riverside, California, United States
  • Englewood, Colorado, United States
  • Delray Beach, Florida, United States
  • Miami, Florida, United States
  • Pensacola, Florida, United States
  • Sarasota, Florida, United States
  • Tamarac, Florida, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Westwood, New Jersey, United States
  • Durham, North Carolina, United States
  • Plymouth Meeting, Pennsylvania, United States
  • Bellaire, Texas, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • McAllen, Texas, United States
  • San Antonio, Texas, United States
  • San Antonio, Texas, United States
  • St. George, Utah, United States
  • Pleven, Bulgaria
  • Sofia, Bulgaria
  • Stara Zagora, Bulgaria
  • Szeged, Csongrad-Csanad, Hungary
  • Győr, Győr-Moson-Sopron, Hungary
  • Debrecen, Hajdú-Bihar, Hungary
  • Budapest, Hungary
  • Amagasaki-shi, Hyōgo, Japan
  • Tomigusuku, Okinawa, Japan
  • Kawachi-Nagano, Osaka, Japan
  • + 16 more on CT.gov