REGN7508 versus apixaban and enoxaparin for preventing blood clots after total knee replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 randomized trial compares REGN7508, an investigational Factor XI–targeting drug, with standard anticoagulants apixaban and enoxaparin (and placebo) for preventing venous thromboembolism after elective unilateral total knee arthroplasty. Adults who meet weight, renal, and lab safety criteria and are undergoing primary unilateral TKA are randomized to a treatment arm and followed for post-operative VTE events, bleeding, drug levels, and anti-drug antibodies. Key exclusions include recent major surgery or trauma, recent significant bleeding, prior thromboembolic disease or known thrombophilia, and severe renal impairment. Multiple U.S. orthopedic clinical sites are enrolling participants and collecting safety and efficacy data.

Why it matters

Who can join: the full rules

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

Where it's running

• Shoals Medical Trials, Inc.
  Sheffield, Alabama, United States Recruiting
• CARI Clinical Trials
  Riverside, California, United States Recruiting
• Denver Metro Orthopedics, P.C. Englewood Location
  Englewood, Colorado, United States Recruiting
• Delray Physician Care Center
  Delray Beach, Florida, United States Recruiting
• Bioresearch Partner
  Miami, Florida, United States Recruiting
• Sacred Heart Health System Inc
  Pensacola, Florida, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.