Clinical trial: A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors (NCT02847637)

Eligibility criteria:
Inclusion Criteria:

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

          -  Diagnosis of severe congenital hemophilia A

          -  Documentation of the details of prophylactic or episodic FVIII treatment and of number
             of bleeding episodes for at least the last 24 weeks

          -  Adequate hematologic function

          -  Adequate hepatic function

          -  Adequate renal function

          -  For women of childbearing potential: agreement to remain abstinent (refrain from
             heterosexual intercourse) or use contraceptive methods that result in a failure rate
             of less than (<) 1 percent (%) per year during the treatment period and for at least 5
             elimination half-lives (24 weeks) after the last dose of study drug

        Exclusion Criteria:

          -  Inherited or acquired bleeding disorder other than hemophilia A

          -  Previous or current treatment for thromboembolic disease or signs of thromboembolic
             disease

          -  Conditions that may increase 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
             (CD) 4 count <200 cells per microliter (cells/mcL) within 24 weeks prior to screening.
             Participants with HIV infection who has CD4 greater than (>) 200 and meet all other
             criteria are eligible

          -  Use of systemic immunomodulators at enrollment or planned use during the study, with
             the exception of anti-retroviral therapy

          -  Participants who are at high risk for thrombotic microangiopathy (TMA) (for example,
             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, may pose additional risk, or would, in the
             opinion of the investigator, preclude the participant's safe participation in and
             completion of the study

          -  Planned surgery (excluding minor procedures) 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 concurrently, within
             last 30 days or 5 half-lives, whichever is shorter

          -  Pregnant or lactating, or intending 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