Clinical trial: Evaluate Efficacy and Safety of Recombinant Factor VIII （rFVIII）Treatment of Severe or Moderately Severe Hemophilia A (NCT02930317)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosis of hemophilia A

          -  Age of 12 Years to 65 Years，Diagnosis of severe （defined as <1% FVIII:C documented in
             medical records） or moderately severe（defined as 1%-5% FVIII:C documented in medical
             records） hemophilia A .Subjects who（Age of 18 Years to 65 Years） have received or are
             currently receiving FVIII products (plasma-derived and/or recombinant FVIII) and have
             had >150 exposure days (EDs) with a FVIII product；The Callan (Age of 12 Years to 17)
             have received FVIII products and have had>50 EDs a FVIII product.

          -  Subjects without a past history of, or current no factor VIII inhibitor. For
             laboratory-based assessments, any Bethesda inhibitor titer Lower than the laboratory's
             normal range or <0.6 BU/mL (BU:Bethesda Units ).

          -  Liver and kidney function in accordance with the standard

          -  Subjects of childbearing potential should agree to use and utilize an adequate method
             of contraception throughout treatment and for at least 28 days after study is stopped

          -  Evidence of a personally or legally acceptable representative (legally acceptable
             representative is only applicable to Callan subjects) signed and dated informed
             consent document indicating that the subject has been informed of all pertinent
             aspects of the study

          -  The part one of subjects subjects who are willing and able to comply with scheduled
             visits, treatment plan, laboratory tests, and other study procedures; Subjects must be
             in a non bleeding state before the administration of rFVIII on Day 1; Subjects should
             not have received an infusion of any FVIII products for at least 3 days (at least 72
             hours) before the administration of rFVIII on Day 1

        Exclusion Criteria:

          -  Current FVIII inhibitor or history of FVIII inhibitor (>0.6 BU/mL )

          -  Diagnosed with any bleeding disorder in addition to hemophilia

          -  Documented Human Immunodeficiency Virus (HIV)

          -  Subjects anticipating elective surgery or other invasive procedure within 1 month
             following study entry

          -  Treatment with an immunomodulatory within 30 days or 5 half lives preceding Day 1,
             whichever is longer

          -  Subjects with known hypersensitivity to the active substance or to any of the
             excipients of rFVIII. Subjects with a known hypersensitivity to Chinese Human
             embryonic kidney cell proteins

          -  Subjects with severe anemia requiring blood transfusion

          -  Subjects with significant hepatic or renal impairment (alanine aminotransferase (ALT)
             or aspartate aminotransferase (AST) >5 x ULN, or total bilirubin >2 x ULN or serum
             creatinine >2 x ULN), prothrombin time >1.5 x ULN, platelet count <80,000 μL. History
             of sensitivity to heparin or heparin induced thrombocytopenia or others
             thrombocytopenia

          -  Patients with heart surgery history requires anticoagulation therapy; Subjects with
             severe heart disease, including myocardial infarction or heart failure Grade 3 or
             higher(NYHA Classification)

          -  Blood pressure unable to be controlled ideally(systolic pressure>150 mmHg，diastolic
             pressure>90 mmHg)

          -  Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation or
             investigational product administration or may interfere with the interpretation of
             study results and, in the judgment of the investigator, would make the subject
             inappropriate for entry into this study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 65 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