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Phase III, randomized, double-blind, multicenter clinical trial to evaluate REGN7508, a monoclonal antibody against factor XI, compared with acetylsalicylic acid for the prevention of symptomatic venous thromboembolism.
THE STUDY AIMS TO DETERMINE HOW EFFECTIVE THE STUDY DRUG IS AT PREVENTING VENOUS THROMBOEMBOLISM (VTE) AND RELATED CONDITIONS AFTER TOTAL KNEE ARTHROPLASTY, COMPARED WITH ACETYLSALICYLIC ACID. VTE INVOLVES A BLOOD CLOT (THROMBUS) THAT FORMS IN A VEIN. PART OF THE CLOT CAN BREAK OFF AND TRAVEL THROUGH THE BLOODSTREAM; THIS IS CALLED AN EMBOLUS. IF IT REACHES THE LUNGS, IT CAN CAUSE A POTENTIALLY LIFE-THREATENING PULMONARY EMBOLISM (PE).
Technical Summary
- PHASE III, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO EVALUATE REGN7508, A MONOCLONAL ANTIBODY AGAINST FACTOR XI, COMPARED WITH ACETYLSALICYLIC ACID FOR THE PREVENTION OF SYMPTOMATIC VENOUS THROMBOEMBOLISM AFTER ELECTIVE TOTAL KNEE ARTHROPLASTY (ROXI-ASPEN).
- Code EudraCT: 2025-520479-25-00
- Protocol number: R7508-DVT-24120
- Promoter: Regeneron
- Molecule/Drug: REGN7508
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