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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-520479-25-00 | EU Trial (CTIS) Number |
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This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called Acetylsalicylic Acid (ASA). 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 compared to acetylsalicylic acid.
The study is looking at several other research questions, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN7508 and Placebo | Experimental |
| |
| Placebo and ASA | 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 symptomatic VTE and all-cause death | Through day 30 visit |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first event of the composite endpoint of symptomatic VTE and all-cause death | Through day 30 visit | |
| Incidence of confirmed symptomatic Deep Vein Thrombosis (DVT) | Through day 30 visit | |
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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 |
|---|---|---|---|---|---|---|
| Horizon Clinical Research | Recruiting | La Mesa | California | 91942 | United States | |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has:
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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| Acetylsalicylic Acid (ASA) | Drug | Administered per the protocol |
|
| Placebo | Drug | Administered per the protocol |
|
| Incidence of confirmed Pulmonary Embolism (PE) |
| Through day 30 visit |
| Incidence of all-cause death | Through day 30 visit |
| Time to first event of the confirmed symptomatic DVT | Through day 30 visit |
| Time to first event of the confirmed PE | Through day 30 visit |
| Time to the all-cause death | Through day 30 visit |
| Incidence of the composite endpoint of major bleeding and Clinically Relevant Non-Major (CRNM) bleeding | Through day 30 visit |
| Incidence of minor bleeding | Through day 30 visit |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | Through day 90 visit |
| Severity of TEAEs | Through day 90 visit |
| Incidence of Anti-drug Antibody (ADA) to REGN7508 | Through day 90 visit |
| Magnitude of ADA to REGN7508 | Through day 90 visit |
| Concentrations of REGN7508 | Through day 90 visit |
| Eisenhower Medical Center |
| Recruiting |
| Rancho Mirage |
| California |
| 92270 |
| United States |
| Sky Ridge Medical Center | Recruiting | Lone Tree | Colorado | 80124 | United States |
| South Florida Joint Replacement Center | Recruiting | Deerfield Beach | Florida | 33064 | United States |
| Medical Research of Westchester - MPLUS Research Network | Recruiting | Miami | Florida | 33165 | United States |
| Phoenix Clinical Research | Recruiting | Tamarac | Florida | 33321 | United States |
| Endeavor Health | Recruiting | Skokie | Illinois | 60076 | United States |
| The Orthopaedic Research Foundation, Inc. | Recruiting | Indianapolis | Indiana | 46278 | United States |
| NextStage Clinical Research, St. Francis Medical Park | Recruiting | Wichita | Kansas | 67214 | United States |
| Velocity Clinical Research, Annapolis | Recruiting | Annapolis | Maryland | 21401 | United States |
| Sinai Hospital of Baltimore, Inc. | Recruiting | Baltimore | Maryland | 21215 | United States |
| Holy Name Medical Center | Recruiting | Teaneck | New Jersey | 07666 | United States |
| University of Rochester Medical Center | Recruiting | Rochester | New York | 14623-5863 | United States |
| Eximia Equihealth Research-Raleigh. LLC | Recruiting | Raleigh | North Carolina | 27612 | United States |
| The Vein and Vascular Center at Raleigh Radiology | Recruiting | Raleigh | North Carolina | 27612 | United States |
| Coastal Vascular Institute, PA | Recruiting | Wilmington | North Carolina | 28401 | United States |
| University of Cincinnati | Recruiting | Cincinnati | Ohio | 45267 | United States |
| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
| Ohio Clinical Trials | Recruiting | Columbus | Ohio | 43212 | United States |
| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213-3108 | United States |
| HD Research - Memorial Hermann Village | Recruiting | Houston | Texas | 77043 | United States |
| NextStage Clinical Research, All American Orthopedics and Sports Medicine | Recruiting | Houston | Texas | 77058 | United States |
| Endeavor Clinical Trials | Withdrawn | San Antonio | Texas | 78240 | United States |
| Carilion Clinic | Recruiting | Roanoke | Virginia | 24015 | United States |
| Spokane Joint Replacement Center | Recruiting | Spokane | Washington | 99218 | United States |
| Sultan Abdul Halim Hospital | Recruiting | Sungai Petani | Kedah | 08000 | Malaysia |
| Hospital Tengku Ampuan Afzan (HTTA) | Recruiting | Kuantan | Pahang | 25100 | Malaysia |
| PMSI Emergency Medicine Institute | Recruiting | Chisinau | MD-2004 | Moldova |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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