A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors

Exclusion Criteria

• •Inherited or acquired bleeding disorder other than hemophilia A
• •Ongoing (or plan to receive during the study) immune tolerance induction (ITI) therapy (prophylaxis regimens with FVIII and/or bypassing agents must be discontinued prior to enrollment). Patients receiving ITI therapy will be eligible following the completion of a 72-hour washout period prior to the first emicizumab administration
• •History of illicit drug or alcohol abuse within 12 months prior to screening, as per the investigator's judgment
• •High risk for thrombotic microangiopathy (TMA) (e.g., have a previous medical or family history of TMA), as per the investigator's judgment
• •Previous (in the past 12 months) or current treatment for thromboembolic disease (with the exception of previous catheter-associated thrombosis for which antithrombotic treatment is not currently ongoing) or current signs of thromboembolic disease
• •Other conditions (e.g., certain autoimmune diseases) that may increase the risk of bleeding or thrombosis
• •History of clinically significant hypersensitivity reaction associated with monoclonal antibody therapies or components of the emicizumab injection
• •Known human immunodeficiency virus (HIV) infection with CD4 count \<200 cells/μL within 6 months prior to screening
• •Use of systemic immunomodulators (e.g., interferon or rituximab) at enrollment or planned use during the study, with the exception of antiretroviral therapy
• •Concurrent disease, treatment, or abnormality in clinical laboratory tests that could interfere with the conduct of the study or that would, in the opinion of the investigator or Sponsor, preclude the patient's safe participation in and completion of the study or interpretation of the study results
• •Receipt of: Emicizumab in a prior investigational study; An investigational drug to treat or reduce the risk of hemophilic bleeds within five half-lives of last drug administration; A non-hemophilia-related investigational drug within last 30 days or five half-lives, whichever is shorter; or, Any concurrent investigational drug.
• •Pregnancy or lactation, or intent to become pregnant during the study
• •Positive serum pregnancy test result within 7 days prior to initiation of emicizumab (females only)