Clinical trial: Study to Compare How the Body Distributes and Excretes the Drugs Jivi (BAY 94-9027) and Adynovi in Patients With Severe Hemophilia A (Bleeding Disorder Resulting From a Lack of Blood Clotting Factor VIII) (NCT04015492)

Eligibility criteria:
Inclusion Criteria:

          -  Participants with severe hemophilia A (baseline FVIII activity FVIII:C <1%),
             determined by measurement at the time of screening (following a washout period of at
             least 72 h after their last FVIII treatment for standard half-life FVIII products or
             of 120 h for extended half-life FVIII products) or from reliable prior documentation
             (e.g. measurement in other clinical studies, result from approved clinical laboratory
             or diagnostic genetic testing).

          -  ≥150 exposure days with FVIII concentrate(s) (plasma-derived or recombinant) as
             supported by medical records.

          -  Body mass index (BMI) within the range 18 kg/m2 to 29.9 kg/m2 (inclusive).

        Exclusion Criteria:

          -  Inability to stop FVIII treatment to complete a minimum of 72 h washout for standard
             half-life FVIII product or 120 h washout for extended half-life FVIII product

          -  Evidence of current or past inhibitor antibody

          -  History of any congenital or acquired coagulation disorders other than hemophilia A

          -  Platelet count <75,000/mm3

          -  Human immunodeficiency virus (HIV) infection with a cluster of differentiation 4
             (CD4+) lymphocyte count of <200/mm3

          -  Abnormal renal function (serum creatinine >2x the upper limit of the normal range
             [ULN])

          -  Active liver disease verified by medical history or persistently elevated alanine
             aminotransferase (ALT) or aspartate aminotransferase (AST) >5x ULN or severe liver
             disease as evidenced by, but not limited to any of the following: International
             Normalized Ratio >1.4, hypoalbuminemia, portal vein hypertension including presence of
             otherwise unexplained splenomegaly and history of esophageal varices

          -  Requirement of any pre-medication to tolerate FVIII treatment (e.g. anti-histamines)

          -  Prior treatment with immunomodulatory agents or chemotherapy within the last 3 months
             prior to study entry or requirement of treatment during the study. The following drugs
             are allowed: α interferon, PEG interferon, highly active anti-retroviral therapy for
             HIV, and/or a total of two courses of pulse treatment with steroid for a maximum of 7
             days at 1 mg/kg or less
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