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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegeneron Pharmaceuticals

About this trial

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

Qualifiers

Is undergoing a primary elective unilateral TKA

Is in good health based on laboratory safety testing as described in the protocol

Body weight ≤130 kg at screening visit as described in the protocol

Disqualifiers

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 as described in the protocol

History of thromboembolic disease or thrombophilia

History of major surgery, including brain, spinal, or ocular, or major trauma within approximately the past 6 months prior to randomization

Trial design

Treatments tested in this trial

  • REGN7508
  • Apixaban
  • Enoxaparin
  • Placebo

Treatment groups

2,000 Participants
are divided into 4 treatment groups

Sponsors and collaborators