Clinical trial: Safety and Efficacy Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients Undergoing Surgery (NCT00157105)

Eligibility criteria:
Inclusion Criteria:

          -  Age >= 5 years

          -  The subject has severe or moderately severe hemophilia A defined by a baseline factor
             VIII level <= 2% of normal documented at screening or historically (e.g., at
             hemophilia diagnosis)

          -  Subjects may enroll regardless of their serologic status for human immunodeficiency
             virus (HIV-1) and hepatitis C virus (HCV)

          -  The subject requires a surgical, dental or other invasive procedure--either elective
             or emergency

          -  The subject has a history of at least 150 exposure days for all other factor VIII
             products (as estimated by the study site investigator) prior to study entry

          -  The subject has a life expectancy of at least 28 days from the day of surgery

          -  The subject has been informed of the nature of the study, agreed to its provisions,
             and signed and dated the informed consent form approved by the appropriate IRB/IEC and
             Baxter BioScience

        Exclusion Criteria:

          -  The subject has a detectable inhibitor to factor VIII in the local hemostasis
             laboratory at the investigative site at the time of enrollment

          -  The subject has a history of inhibitor to factor VIII > 1.0 BU. Note: If the subject
             has a history of an inhibitor titer > 1.0 BU at any time prior to enrollment but
             demonstrated expected clinical responses to conventional doses of factor VIII therapy,
             the subject may enroll

          -  The subject has known hypersensitivity to Recombinate

          -  The subject is currently participating in another investigational drug study, or has
             participated in any clinical trial involving an investigational drug within 30 days of
             study entry

          -  The subject has clinical and/or laboratory evidence of abnormal hemostasis from causes
             other than hemophilia A (e.g., late-stage chronic liver disease, immune
             thrombocytopenic purpura, disseminated intravascular coagulation)

          -  The subject is identified by the investigator as being unable or unwilling to
             cooperate with study procedures.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 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? 0