REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
NCT ID: NCT07015905
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
2000 participants
INTERVENTIONAL
2025-06-25
2027-05-12
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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IV REGN7508
REGN7508
Administered per the protocol
IV Placebo, SC REGN7508
REGN7508
Administered per the protocol
Placebo
Administered per the protocol
IV Placebo, apixaban
Apixaban
Administered per the protocol
Placebo
Administered per the protocol
IV Placebo, enoxaparin
Enoxaparin
Administered per the protocol
Placebo
Administered per the protocol
Interventions
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REGN7508
Administered per the protocol
Apixaban
Administered per the protocol
Enoxaparin
Administered per the protocol
Placebo
Administered per the protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Shoals Medical Trials, Inc.
Sheffield, Alabama, United States
CARI Clinical Trials
Riverside, California, United States
Denver Metro Orthopedics, P.C. Englewood Location
Englewood, Colorado, United States
Delray Physician Care Center
Delray Beach, Florida, United States
Bioresearch Partner
Miami, Florida, United States
Sacred Heart Health System Inc
Pensacola, Florida, United States
Gulfcoast Research Institute
Sarasota, Florida, United States
Phoenix Clinical Research
Tamarac, Florida, United States
Sinai Hospital of Baltimore, Inc.
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Curalta Clinical Trials
Westwood, New Jersey, United States
HD Research - First Surgical Hospital
Bellaire, Texas, United States
NextStage Clinical Research, All American Orthopedics and Sports Medicine
Houston, Texas, United States
Futuro Clinical Trials
McAllen, Texas, United States
Flourish Research - San Antonio (Formerly Clinical Trials of Texas)
San Antonio, Texas, United States
Multi-profile Hospital for Active Treatment Hearth and Brain EAD
Pleven, , Bulgaria
Kansai Rosai Hospital
Amagasaki-shi, Hyōgo, Japan
Yuuai Medical Center
Tomigusuku, Okinawa, Japan
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, Osaka, Japan
Osaka Saiseikai Nakatsu Hospital
Kita-Ku, Osaka, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Saga University Hospital
Saga, , Japan
Liepajas regionala slimnica; SIA
Liepāja, , Latvia
Rigas 2 slimnica, SIA
Riga, , Latvia
Hospital of Traumatology and Orthopaedics
Riga, , Latvia
ORTO Klinika
Riga, , Latvia
Vidzemes slimnica
Valmiera, , Latvia
Lietuvos sveikatos mokslu universiteto Kauno ligonine
Kaunas, , Lithuania
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik
Kaunas, , Lithuania
Vsi Klaipedos Universitetine Ligonine
Klaipėda, , Lithuania
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. z o.o.
Krakow, , Poland
Countries
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Central Contacts
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Other Identifiers
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2025-520478-20-00
Identifier Type: CTIS
Identifier Source: secondary_id
R7508-DVT-24116
Identifier Type: -
Identifier Source: org_study_id
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