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Clinical trial of the effects of abelacimab and apixaban on venous thromboembolism recurrence and bleeding in patients with cancer-associated VTE.
THE PRIMARY OBJECTIVE OF THIS STUDY IS TO ASSESS WHETHER ABELACIMAB IS NON-INFERIOR TO APIXABAN IN PREVENTING VTE RECURRENCE AT 6 MONTHS AFTER RANDOMIZATION IN PATIENTS WITH CANCER AND NEWLY DIAGNOSED VTE. IF NON-INFERIORITY IS DEMONSTRATED, SUPERIORITY WILL BE ASSESSED. WE AIM TO ASSESS WHETHER MONTHLY TREATMENT WITH ABELACIMAB, ADMINISTERED INTRAVENOUSLY (I.V.) ON DAY 1 FOLLOWED BY SUBCUTANEOUS (S.C.) DOSING ONCE A MONTH, IS NON-INFERIOR TO TWICE-DAILY (2 V/D) ORAL ADMINISTRATION OF APIXABAN IN THE PREVENTION OF VTE RECURRENCE IN PATIENTS WITH CANCER AND NEWLY DIAGNOSED VTE. THE STUDY WILL ALSO ANALYZE THE SUPERIORITY IN PREVENTING THE COMPOSITE OF MAJOR BLEEDING EPISODES AND NGCR WITH ABELACIMAB COMPARED TO APIXABAN IN THIS POPULATION. THIS STUDY WILL AID THE WORLDWIDE REGISTRATION OF ABELACIMAB FOR THE TREATMENT OF CA VTE.
- PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL, MASKED ENDPOINT STUDY COMPARING THE EFFECT OF ABELACIMAB RELATIVE TO APIXABAN ON VENOUS THROMBOEMBOLISM (VTE) RECURRENCE AND BLEEDING IN PATIENTS WITH CANCER-ASSOCIATED VTE. IMMUNOTHERAPY
- Code EudraCT: 2021-003076-14
- Protocol number: ANT-007
- Promoter: Anthos Therapeutics
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