Clinical trial: Early Prophylaxis Immunologic Challenge (EPIC) Study (NCT01376700)

Eligibility criteria:
Inclusion Criteria:

          -  Participants with severe and moderately severe hemophilia A (FVIII ≤ 2%)

          -  Participants < 1 year of age

          -  Participants must have ≤ 3 exposure days (EDs) to any FVIII concentrate or
             FVIII-containing product used for treatment of minor bleeds (bleeds requiring no more
             than 2 infusions per event), or for preventative or precautionary infusions following
             possible injury

          -  Participants with prior circumcision are allowed to enroll only if bleeding issues
             related to circumcision were the cause for the original diagnosis of hemophilia A and
             no more than 2 EDs of FVIII treatment were required

          -  Adequate venous access (without need for central venous access device
             (CVAD)-placement) as determined by the physician

          -  Written informed consent from legally authorized representative(s)

        Exclusion Criteria:

          -  Life-threatening conditions (intracranial hemorrhage, severe trauma) or requirement
             for surgery at the time of enrollment

          -  Evidence of inhibitor ≥ 0.6 Bethesda Unit (BU) in Nijmegen-modified Bethesda Assay at
             study start (samples may be retested using lupus-insensitive inhibitor tests to reduce
             the number of false positive inhibitor test results)

          -  Inherited or acquired hemostatic defect other than hemophilia A

          -  Any clinically significant, chronic disease other than hemophilia A

          -  Known hypersensitivity to ADVATE or any of its constituents

          -  Any planned elective surgery that cannot be postponed until after the first 20 EDs

          -  Participation in the Hemophilia Inhibitor Previously Untreated Patient Study

          -  Application of red blood cell, platelet, or leukocyte concentrates, or plasma

          -  Administration of any medication affecting coagulation or platelet function

          -  Systemic administration of any immunomodulatory drug (eg, chemotherapy, intravenous
             glucocorticoids)

          -  Participation in another clinical study involving an investigational product (IP) or
             device within 30 days prior to study enrollment or during the course of this study
Male
No healthy subjects accepted to join the trial.

Subject must be at most 1 Year

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