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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-520478-20-00 | EU Trial (CTIS) Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV REGN7508 | Experimental |
| |
| IV Placebo, SC REGN7508 | Experimental |
| |
| IV Placebo, apixaban | Active Comparator |
| |
| IV Placebo, enoxaparin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN7508 | Drug | Administered per the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death] | Through day 12 visit, approximately 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-first event of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death) | Through day 12 visit, approximately 14 days | |
| Incidence of confirmed symptomatic Deep Venous Thrombosis (DVT) | Through day 12 visit, approximately 14 days |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shoals Medical Trials, Inc. | Recruiting | Sheffield | Alabama | 35660 | United States | |
When Regeneron has:
When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| Apixaban | Drug | Administered per the protocol |
|
| Enoxaparin | Drug | Administered per the protocol |
|
|
| Placebo | Drug | Administered per the protocol |
|
| Incidence of confirmed Pulmonary Embolism (PE) | Through day 12 visit, approximately 14 days |
| Incidence of VTE-related death | Through day 12 visit, approximately 14 days |
| Time-to-first event of confirmed symptomatic DVT | Through day 12 visit, approximately 14 days |
| Time-to-first event of confirmed PE | Through day 12 visit, approximately 14 days |
| Time to VTE-related death | Through day 12 visit, approximately 14 days |
| Incidence of the composite endpoint of major and Clinically Relevant Non-Major (CRNM) bleeding | Through day 12 visit, approximately 14 days |
| Incidence of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death) | Through day 12 visit, approximately 14 days |
| Incidence of minor bleeding | Through day 12 visit, approximately 14 days |
| Incidence of Treatment Emergent Adverse Events (TEAEs) | Approximately day 90 |
| Occurrence of Anti-Drug Antibodies (ADA) to REGN7508 | Approximately day 90 |
| Magnitude of ADA to REGN7508 | Approximately day 90 |
| Concentrations of REGN7508 | Approximately day 90 |
| CARI Clinical Trials |
| Recruiting |
| Riverside |
| California |
| 92504 |
| United States |
| Denver Metro Orthopedics, P.C. Englewood Location | Recruiting | Englewood | Colorado | 80113 | United States |
| Delray Physician Care Center | Recruiting | Delray Beach | Florida | 33445 | United States |
| Bioresearch Partner | Recruiting | Miami | Florida | 33175 | United States |
| Sacred Heart Health System Inc | Recruiting | Pensacola | Florida | 32504 | United States |
| Gulfcoast Research Institute | Recruiting | Sarasota | Florida | 34232 | United States |
| Phoenix Clinical Research | Recruiting | Tamarac | Florida | 33321 | United States |
| Sinai Hospital of Baltimore, Inc. | Recruiting | Baltimore | Maryland | 21215 | United States |
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| Curalta Clinical Trials | Recruiting | Westwood | New Jersey | 07675 | United States |
| Duke University Health System (Duke Health), Duke University Hospital | Recruiting | Durham | North Carolina | 27710 | United States |
| Keystone Clinical Studies LLC, dba Flourish Research | Recruiting | Plymouth Meeting | Pennsylvania | 19462 | United States |
| HD Research - First Surgical Hospital | Recruiting | Bellaire | Texas | 77401 | United States |
| University of Texas (UT); Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
| NextStage Clinical Research, All American Orthopedics and Sports Medicine | Recruiting | Houston | Texas | 77058 | United States |
| Futuro Clinical Trials | Recruiting | McAllen | Texas | 78501 | United States |
| Flourish Research - San Antonio (Formerly Clinical Trials of Texas) | Recruiting | San Antonio | Texas | 78229 | United States |
| DRx Clinical Research, LLC; South Texas Bone and Joint Institute | Recruiting | San Antonio | Texas | 78249 | United States |
| DRx Clinical Research, LLC | Recruiting | St. George | Utah | 84770 | United States |
| Multi-profile Hospital for Active Treatment Hearth and Brain EAD | Recruiting | Pleven | 5804 | Bulgaria |
| Multiprofile Hospital for Active Treatment; Sveta Sofia EOOD (MBAL Sveta Sofia), | Recruiting | Sofia | 1404 | Bulgaria |
| University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich" | Recruiting | Stara Zagora | 6003 | Bulgaria |
| Gyor-Moson-Sopron Varmegyei Egyetemi Oktato Korhaz | Recruiting | Győr | Győr-Moson-Sopron | 9024 | Hungary |
| University of Debrecen | Recruiting | Debrecen | Hajdú-Bihar | 4031 | Hungary |
| Semmelweis University | Recruiting | Budapest | 1082 | Hungary |
| Kansai Rosai Hospital | Recruiting | Amagasaki-shi | Hyōgo | 660-8511 | Japan |
| Yuuai Medical Center | Recruiting | Tomigusuku | Okinawa | 901-0224 | Japan |
| National Hospital Organization Osaka Minami Medical Center | Recruiting | Kawachi-Nagano | Osaka | 586-8521 | Japan |
| Osaka Saiseikai Nakatsu Hospital | Recruiting | Kita-Ku | Osaka | 530-0012 | Japan |
| Juntendo University Hospital | Recruiting | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Saga University Hospital | Recruiting | Saga | 849-8501 | Japan |
| Liepajas regionala slimnica; SIA | Recruiting | Liepāja | LV-3414 | Latvia |
| Rigas 2 slimnica, SIA | Recruiting | Riga | LV-1004 | Latvia |
| Hospital of Traumatology and Orthopaedics | Recruiting | Riga | LV-1005 | Latvia |
| ORTO Klinika | Recruiting | Riga | LV-1005 | Latvia |
| Vidzemes slimnica | Recruiting | Valmiera | LV-4201 | Latvia |
| Lietuvos sveikatos mokslu universiteto Kauno ligonine | Recruiting | Kaunas | LT-47144 | Lithuania |
| Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik | Recruiting | Kaunas | LT-50161 | Lithuania |
| Vsi Klaipedos Universitetine Ligonine | Recruiting | Klaipėda | LT-92288 | Lithuania |
| Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. z o.o. | Recruiting | Krakow | 31-826 | Poland |
| Uniwersytecki Szpital Kliniczny nr.2 Uniwersytetu Medycznego w Lodzi | Recruiting | Lodz | 90-549 | Poland |
| Samodzieny Publiczny Zaklad Opieki Zdorowotne (SP ZOZ) Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi - Hematology | Recruiting | Lodz | 92-213 | Poland |
| Arensia Clinics S.R.L | Recruiting | Bucharest | 011658 | Romania |
| ARENSIA Exploratory Medicine, County Hospital Cluj-Napoca | Recruiting | Cluj-Napoca | 400006 | Romania |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C522181 | apixaban |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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