Clinical trial: China ADVATE PTP Study (NCT02170402)

Eligibility criteria:
Main Inclusion Criteria:

          -  Ethnic Chinese

          -  is of any age

          -  has a documented diagnosis of severe or moderately severe hemophilia A (congenital
             FVIII deficiency: baseline Factor VIII (FVIII) ≤ 2%)

          -  has documented and verified >50 exposure days (EDs) to FVIII (recombinant or plasma
             derived)

          -  is receiving on-demand treatment with FVIII at the time of enrolment in this study

          -  has negative history of inhibitor development

          -  is HIV negative or HIV positive with stable disease and CD4+ count ≥ 200 cells per
             mm^3

          -  is negative for Hepatitis C virus (HCV); Or participant is HCV positive with chronic
             stable hepatitis as assessed by investigator

        Main Exclusion Criteria:

          -  has prior history of hypersensitivity or anaphylaxis associated with receipt of FVIII

          -  is diagnosed with other bleeding disorder(s) other than hemophilia A, including but
             not limited to thrombocytopenia (platelet count < 100000 /mL)

          -  has been exposed to an investigational product (IP) within 30 days prior to the
             screening visit or is scheduled to participate in another clinical study involving an
             IP or investigational device during participation in the study

          -  is planned, or likely to have surgery during the study period

          -  has end-stage renal failure or evidence of a severe or uncontrolled systemic disease
             as judged by the investigator

          -  has active hepatic disease (alanine aminotransferase (ALT) and aspartate
             aminotransferase (AST) levels > 5 times the upper limit of normal)

          -  has clinical or laboratory evidence of severe liver impairment including (but not
             limited to) a recent & persistent international normalized ratio (INR) >1.4, and/or
             the presence of splenomegaly and/or significant spider angioma on physical exam,
             and/or a history of esophageal hemorrhage or documented esophageal varices

          -  is a family member of the investigator or site staff
Male
No healthy subjects accepted to join the trial.



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