Clinical trial: Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects (NCT00868530)

Eligibility criteria:
Inclusion Criteria:

          -  Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia A
             (FVIII activity: more than 5%, 1-5%, or less than 1%, respectively)

          -  Subjects with previous exposure to FVIII replacement therapy

          -  If human immunodeficiency virus (HIV) positive, documented cluster of differentiation
             (CD4) count more than 200/µL within 6 months of study entry

        Exclusion Criteria:

          -  Diagnosed with any bleeding disorder in addition to hemophilia A

          -  Current FVIII inhibitor or history of FVIII inhibitor (defined as positive result of
             the reporting laboratory)

          -  Subject has no history of exposure to FVIII products (previously untreated patient
             [PUP])

          -  Subject is currently utilizing primary FVIII prophylaxis

          -  Subjects anticipating elective surgery that may be planned to occur in the 6 months
             following study entry

          -  Treated with immunomodulatory therapy within 30 days prior to study entry or planned
             use for the duration of their study participation

          -  Participated in another investigational drug or device study within 30 days prior to
             study entry or planned participation for the duration of their study participation

          -  Subjects with a known hypersensitivity to hamster protein

          -  Significant hepatic or renal impairment (alanine aminotransferase [ALT] and aspartate
             aminotransferase [AST] >5 x upper limit of normal [ULN], bilirubin >2 mg/dL or serum
             creatinine >1.25 x ULN)

          -  Prothrombin Time >1.5 x ULN

          -  Platelet count <80,000 / µL

          -  Pregnant or breastfeeding women

          -  Unwilling or unable to follow the terms of the protocol

          -  Any condition which may compromise the subject's ability to comply with and/or perform
             study-related activities or that poses a clinical contraindication to study
             participation, in the opinion of the Investigator or Sponsor
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 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? Contradiction