Clinical trial: Study of FVIIa Variant BAY86-6150 (B0189) in Subjects With Moderate or Severe Hemophilia Types A or B With or Without Inhibitors (NCT01921855)

Eligibility criteria:
Inclusion Criteria:

          -  History of moderate or severe congenital hemophilia A or B with or without inhibitors
             to Factor VIII (FVIII) or Factor IX (FIX)

          -  Male subjects 18-65 years of age inclusive

          -  Able to dismiss factor replacement therapy during the course of the study unless
             required for the treatment of an acute bleeding episode

          -  Written informed consent

          -  Willing and able to comply with the requirements of the protocol

          -  Have adequate venous access

          -  Willing to use an effective method of contraception until Day 30 of their study
             participation

        Exclusion Criteria:

          -  Received factor replacement therapy or treatment with any other procoagulant
             therapeutics, or any antifibrinolytic agents, including blood products, at anytime
             within 5 days prior to administration of investigational medicinal product (IMP)

          -  Planned administration of factor replacement therapy or treatment with any other
             procoagulant therapeutics or any antifibrinolytic agents, including blood products, at
             anytime during the study period

          -  Acute bleeding episode or any ongoing bleeding episode at any time within 7 days prior
             to administration IMP

          -  Clinically relevant coagulation disorder other than congenital hemophilia A or B

          -  History of angina or receiving treatment for angina

          -  History of coronary atherosclerotic disease, disseminated intravascular coagulopathy,
             or stage 2 hypertension defined as systolic blood pressure (SBP) >/= 160 mmHg or
             diastolic blood pressure (DBP) >/= 90 mmHg

          -  History of transient ischemic attack, stroke, myocardial infarction, coronary artery
             disease, congestive heart failure, or thromboembolic event

          -  Active infection on day of IMP administration or septicemia at any time within 30 days
             prior to administration of IMP
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