Clinical trial: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants With Inhibitors (NCT02622321)

Eligibility criteria:
Inclusion Criteria:

          -  Body weight >/= 40 kilograms (kg) at the time of screening

          -  Diagnosis of congenital hemophilia A of any severity and documented history of
             high-titer inhibitor ( that is [i.e.], >/= 5 Bethesda Units [BU])

          -  Documentation of treatment with episodic or prophylactic bypassing agents for at least
             the last 24 weeks

          -  >/= 6 bleeds in the last 24 weeks prior to screening (if on an episodic bypassing
             agent regimen) or >/=2 bleeds in the last 24 weeks prior to screening (if on a
             prophylactic bypassing agent regimen)

          -  Adequate hematologic, hepatic and renal function

          -  For women who are not postmenopausal or surgically sterile: agreement to remain
             abstinent or use single or combined highly effective contraceptive methods

        Exclusion Criteria:

          -  Participants with inherited or acquired bleeding disorder other than hemophilia A

          -  Participants with ongoing (or plan to receive during the study) immune tolerance
             induction therapy or prophylaxis with Factor VIII (FVIII), with the exception of
             participants who have received a treatment regimen of FVIII prophylaxis with
             concurrent bypassing agent prophylaxis

          -  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

          -  Participants with other conditions (for example [e.g.], certain autoimmune diseases)
             that may increase the risk of bleeding or thrombosis

          -  History of clinically significant hypersensitivity associated with monoclonal antibody
             therapies or components of the emicizumab injection

          -  Known human immunodeficiency virus (HIV) infection with cluster of differentiation 4
             (CD4) count < 200 cells per microliter (cells/mcL) within 24 weeks prior to screening

          -  Use of systemic immunomodulators (e.g., interferon or rituximab) at enrolment or
             planned use during the study, with the exception of antiretroviral therapy

          -  Participants who are at high risk for thrombotic microangiopathy (TMA; e.g., have a
             previous medical or family history of TMA), in the investigator's judgment

          -  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 participant's safe participation in and
             completion of the study or interpretation of the study results

          -  Planned surgery (excluding minor procedures such as tooth extraction or incision and
             drainage) during the study

          -  Receipt of emicizumab in a prior investigational study; An investigational drug to
             treat or reduce the risk of hemophilic bleeds within 5 half-lives of last drug
             administration; A non-hemophilia-related investigational drug within last 30 days or 5
             half-lives, whichever is shorter; An investigational drug concurrently

          -  Unwillingness to use highly effective contraception methods for the specified duration
             in the protocol (females only, unless required otherwise by the local health
             authority)

          -  Clinically significant abnormality on screening evaluations or laboratory tests that,
             in the opinion of the investigator, may pose an additional risk in administering study
             drug to the participant

          -  Pregnancy or lactation, or intent to become pregnant during the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.


Patient description (medical language): A 20-year-old man comes to the emergency due to bleeding after a tooth extraction.  The bleeding has persisted for approximately 30 minutes despite constant direct pressure.  He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%.

Patient description (patient's own words): I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%.

Does the patient match the trial criteria? Contradiction