Stopped: The Sponsor decided to terminate the study early for several reasons (low enrollment, limited variety of surgery types, and available scientific data).
This Phase IV, multicenter study will evaluate whether participants with Hemophilia A (PwHA) with or without inhibitors receiving emicizumab prophylaxis can safely undergo minor surgical procedures without additional prophylactic bypassing agents (BPA; for participants with inhibitors) or factor VIII (FVIII; for participants without inhibitors).
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Percentage of Participants Without Excessive Bleeding at Surgical Sites and Did Not Require BPA/FVIII Use for Bleeding Related to the Surgery, From the Start of Surgery Until Discharge, as Measured by the ISTH Hemostatic Efficacy Scale
Timeframe: Determined at the time of discharge (within approximately 48 hours after surgery)
Percentage of Participants With Excessive Bleeding at Surgical Sites and Required BPA/FVIII Use for Treating Bleeding Related to the Surgery, From the Start of Surgery Until Discharge, as Measured by the ISTH Hemostatic Efficacy Scale
Timeframe: Determined at the time of discharge (within approximately 48 hours after surgery)
Percentage of Participants Who, After Being Discharged From Surgery, Experienced Bleeds That Were Either Related or Unrelated to Surgery and Also Required BPA/FVIII Use
Timeframe: Within 48 hours (if discharged home), and 8 and 28 days after surgery
Emicizumab Plasma Concentration on the Day of Surgery
Timeframe: Approximately 24 hours prior to surgery
Safety Summary of the Number of Participants With at Least One Adverse Event
Timeframe: From Baseline up to 30 days after surgery
Percentage of Participants With Surgical Complications Requiring Hospitalization or Return to Surgery
Timeframe: Within 48 hours after surgery, and 8 and 28 days after initial surgery
Percentage of Participants Who Needed Blood/Blood Product Transfusions During Surgery
Timeframe: Within 48 hours after surgery, and 8 and 28 days after initial surgery