Clinical trial: A Study to Assess Pharmacokinetics and Pharmacodynamics Following Administration of BAY1093884 in Patients With Severe Hemophilia (NCT03481946)

Eligibility criteria:
Inclusion Criteria:

          -  Males with severe congenital hemophilia A or B defined as <1% FVIII or <2% FIX
             concentration by measurement at the time of screening or from reliable prior
             documentation (e.g., measurement in other clinical Bayer trials, or diagnostic genetic
             testing)

          -  Male with any inhibitor titer at screening or prior to screening at any time from
             medical records. Subjects may be receiving a bypassing agent (rFVIIa; NovoSeven and/or
             aPCC; FEIBA) for treatment.

          -  Age: 18 to 65 years at screening

          -  BMI: 18 to 29.9 kg/m2

        Exclusion Criteria:

          -  Subjects with known bleeding disorders (such as von Willebrand factor [vWF]
             deficiency, FXI deficiency, platelet disorders, or known acquired or inherited
             thrombophilia etc.) other than congenital Hemophilia A or B with or without inhibitors

          -  History of angina pectoris or treatment for angina pectoris

          -  History of coronary and/or peripheral atherosclerotic disease, congestive heart
             failure, disseminated intravascular coagulopathy, or stage 2 hypertension defined as
             systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg
             even if controlled

          -  History of thrombophlebitis, venous/arterial thromboembolic diseases (particularly
             deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction,
             cerebrovascular accident, ischemic heart disease, transient ischemic attack)

          -  Known or suspected hypersensitivity of the immune system, history of anaphylactic
             reaction, known severe allergies, non-allergic drug reactions, or multiple drug
             allergies

          -  Subjects with inhibitors treated with FEIBA, who are not willing to accept rFVIIa
             (NovoSeven) for the treatment of any bleeds occurring either between screening and
             dosing or after study drug administration, and until the end of the study.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 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