Clinical trial: Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia A (NCT02888223)

Eligibility criteria:
Inclusion Criteria:

          -  12 to 65 years old;

          -  The activity of the coagulation factor VIII (FVIII:C) ≤2%, and was previously treated
             with FVIII concentrate(s) for a minimum of 50 exposure days (EDs) prior to study entry

          -  Non-bleeding state (No clinical manifestations of active hemorrhage);

          -  Negative assays for FVIII inhibitors (<0.6 BU/mL);

          -  The platelet count is normal；

          -  Normal prothrombin time or INR ≤1.5；

          -  Given informed consent

        Exclusion Criteria:

          -  Hypersensitivity to recombinant coagulation factor VIII concentrate or any of the
             excipients ;allergic to heterologous proteins (e.g. murine, bovine or hamster origin);

          -  Family history or history of FVIII inhibitors (≥0.6 Bethesda Units [BU] mL-1);

          -  Received an infusion of any FVIII for on-demand therapy or prophylaxis within 4 days
             prior to study entry (including rFVIII, plasma-derived factor VIII [pdFVIII],
             cryoprecipitate and whole blood);

          -  Significant hepatic or renal impairment (ALT and AST ≥2×ULN; BUN and Cr≥2×ULN);

          -  HIV seropositive;

          -  Abnormal hemostasis from causes other than hemophilia A；

          -  Patients with severe heart disease, including myocardial infarction, heart failure
             (III or higher level);

          -  Patients who received any anticoagulant or antiplatelet therapy within one week
             (including NSAIDs) or need to receive an anticoagulant or antiplatelet therapy during
             the period of clinical trials;

          -  Alcoholism, drug abuse, mental disorders and mental retardation;

          -  Elective surgery planned during the process of study;

          -  Patients who previously participated in the other clinical trials prior to study
             entry;

          -  The patient or parent/legal guardian is unable or unwilling to sign an informed
             consent form or to comply with the requirements of clinical protocol;

          -  Other conditions confirmed by the researchers, resulting in that patients are unable
             to benefit from clinical observation;
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