Clinical trial: A Study of Emicizumab Administered Subcutaneously (SC) in Pediatric Participants With Hemophilia A and Factor VIII (FVIII) Inhibitors (NCT02795767)

Eligibility criteria:
Inclusion Criteria:

          -  Children less than (<) 12 years of age, with allowance for participants 12 to 17 years
             of age who weigh <40 kilograms (kg) (Cohort A only); and participants <2 years of age
             will be allowed to participate only after the protocol-defined interim data review
             criteria are met (Cohort A only)

          -  Diagnosis of congenital hemophilia A of any severity and documented history of
             high-titer inhibitor (that is [i.e.], greater than or equal to [>/=] 5 bethesda units
             [BU])

          -  Requires treatment with bypassing agents

          -  Adequate hematologic, hepatic, and renal function

        Exclusion Criteria:

          -  Inherited or acquired bleeding disorder other than hemophilia A

          -  Ongoing (or planning to receive during the study) immune tolerance induction (ITI)
             therapy or prophylaxis treatment with FVIII

          -  Previous (in the past 12 months) or current treatment for thromboembolic disease or
             signs of thromboembolic disease

          -  Other disease that may increase risk of bleeding or thrombosis

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

          -  Known infection with human immunodeficiency virus (HIV) or hepatitis B or C virus

          -  Use of systemic immunomodulators at enrollment or planned use during the study period

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

          -  Inability (or unwillingness by caregiver) to receive (allow receipt of) blood or blood
             products (or any standard-of-care treatment for a life-threatening condition)

          -  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 judgement
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.

Subject must be at most 17 Years

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