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AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF MARSTACIMAB PROPHYLAXIS IN SEVERE (COAGULATION FACTOR ACTIVITY <1%) HEMOPHILIA A PARTICIPANTS WITH OR WITHOUT INHIBITORS OR MODERATELY SEVERE TO SEVERE HEMOPHILIA B PARTICIPANTS (COAGULATION FACTOR ACTIVITY ≤2%) WITH OR WITHOUT INHIBITORS

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Trial Profile

AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF MARSTACIMAB PROPHYLAXIS IN SEVERE (COAGULATION FACTOR ACTIVITY <1%) HEMOPHILIA A PARTICIPANTS WITH OR WITHOUT INHIBITORS OR MODERATELY SEVERE TO SEVERE HEMOPHILIA B PARTICIPANTS (COAGULATION FACTOR ACTIVITY ≤2%) WITH OR WITHOUT INHIBITORS

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 28 Dec 2024

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At a glance

  • Drugs Marstacimab (Primary)
  • Indications Haemophilia A; Haemophilia B
  • Focus Adverse reactions
  • Acronyms B7841007
  • Sponsors Pfizer

Most Recent Events

  • 12 Nov 2024 Planned number of patients changed from 165 to 245.
  • 03 Jan 2024 Planned number of patients changed from 145 to 165.
  • 12 Dec 2023 Results of 1b/2 study (NCT02974855), its long-term follow-up (LTFU; NCT03363321), the pivotal phase 3 BASIS study (NCT03938792), and its long-term extension (LTE; NCT05145127), presented at the 65th American Society of Hematology Annual Meeting and Exposition

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