Clinical trial: Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients (NCT00914459)

Eligibility criteria:
Inclusion Criteria:

          -  Male subjects less than 12 years of age with a documented history of severe hemophilia
             A (FVIII:C less than 1%).

          -  Subjects who are less than 6 years of age must have had at least 50 Exposure Days
             (EDs) to prior FVIII products (including blood products).

          -  Subjects who are equal to or greater than 6 years of age must have had greater than
             150 EDs to prior FVIII products (including blood products).

        Exclusion Criteria:

          -  For laboratory assessments, any measured Bethesda inhibitor titer equal to or greater
             than 0.6 BU, regardless of the laboratory normal range, or any Bethesda inhibitor
             titer greater than ULN for the testing laboratory at the time of screening.

          -  Any other bleeding disorder in addition to hemophilia A.

          -  Treatment with any investigational drug or device within 30 days before the time of
             signing the parental informed consent/assent form.

          -  Major surgery planned to occur during the course of the study.

          -  Regular (e.g., daily; every other day) use of agents or medications known to influence
             platelet function such as aspirin or certain nonsteroidal anti-inflammatory drugs
             (NSAIDS).

          -  Regular, concomitant therapy with immunomodulating drugs (e.g., intravenous
             immunoglobulin [IVIG], routine systemic corticosteroids), or currently receiving
             immune tolerance induction (ITI) for inhibitor treatment.

          -  The subject is receiving treatment for HIV or hepatitis infection (unless the subject
             is on a stable antiviral regimen [i.e., consistent treatment regimen for at least 3
             months before the parental informed consent/assent form is signed]).

          -  Platelet count less than 100,000/µL.

          -  Prothrombin time (PT) equal to or greater than 1.25 x ULN, or international normalized
             ratio (INR) equal to or greater than 1.5.

          -  Known hypersensitivity to hamster protein.
Male
No healthy subjects accepted to join the trial.

Subject must be at most 11 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