Clinical trial: Pharmacokinetics of rFVIIIFc at Two Vial Strengths (NCT02083965)

Eligibility criteria:
Key Inclusion Criteria:

          -  Have severe hemophilia A

          -  Previously treated subject, defined as having at least 150 documented prior exposure
             days to any recombinant and/or plasma-derived FVIII and/or cryoprecipitate products
             (other than any use of rFVIIIFc- study drug or commercial product) at Day 1. Fresh
             frozen plasma treatment must not be considered in the count for documented exposure
             days.

          -  No history of a positive inhibitor test or clinical signs of decreased response to
             FVIII administrations. Family history of inhibitors will not exclude subjects.

          -  No measurable inhibitor activity using the Nijmegen-modified Bethesda assay at
             Screening.

          -  Platelet count ≥100,000 platelets/μL at screening

          -  CD4 lymphocytes >200 mm3 if known as HIV antibody positive at screening.

          -  Viral load of <400 copies/mL if known HIV antibody positive at screening.

        Key Exclusion Criteria:

          -  Subject is at high risk of bleeding during the 5-day period between the first and
             second injections for PK analyses, as per Investigator discretion.

          -  Previous treatment with rFVIIIFc as study drug or commercial product.

          -  Other coagulation disorder(s) in addition to hemophilia A.

          -  History of hypersensitivity or anaphylaxis associated with any FVIII or IV
             immunoglobulin administration.

          -  Currently taking (or likely to require during the study) acetylsalicylic acid (ASA),
             except for low-dose ASA as prophylaxis (other nonsteroidal anti-inflammatory drugs are
             permitted).

          -  Concurrent systemic treatment with immunosuppressive drugs within 12 weeks prior to
             Day 1. Exceptions to this include: ribavirin for treatment of hepatitis C virus (HCV),
             and/or systemic steroids (a total of 2 courses of pulse treatments lasting no more
             than 7 days at a dose of ≤1 mg/kg within 12 weeks prior to Day 1) and/or inhaled
             steroids.

        NOTE: Other protocol-defined inclusion/exclusion Criteria May Apply
Male
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? 1