Clinical trial: Safety,Efficacy and Pharmacokinetics Evaluation of SCT800 in Previously Treated Paediatric Patients With Severe Haemophilia A. (NCT03947320)

Eligibility criteria:
Inclusion Criteria:

          -  Aged <12 years ;

          -  Male severe (central laboratory tested FVIII:C <1%) hemophilia A patients;

          -  Previously received FVIII treatment (prophylactic or bleeding treatment), have the
             relevant records and are verified to have accumulated EDs ≥150 days（6≤age<12years
             old）and EDs >50 days（age <6 years old）;

          -  The bleeding treatment records of at least 3 months before screening can be obtained;

          -  Negative FVIII inhibitor assay results (laboratory tested Nijmegen-Bethesda assay
             result <0.6 BU/mL);

          -  HIV negative; if HIV positive, the viral load <200 particles/uL or <400,000 copies/mL,
             and HIV patients must satisfy CD4+ count >200/μL;

          -  The patient or his guardian voluntarily signed the Informed Consent Form.

        Exclusion Criteria:

          -  Known allergy to any coagulation factor VIII or any excipient; known allergy to
             bovine, rodent or hamster bovine;

          -  Has a history or family history of blood coagulation factor VIII inhibitor;

          -  Platelet count <100 × 109/L;

          -  Clinical liver function test ((glutamic-pyruvic transaminase, glutamic-pyruvic
             transaminase) ≥ five times the upper limit of normal (ULN) or clinical kidney function
             test （creatinine) ≥ two times the ULN;

          -  International normalized ratio (INR) >1.5;

          -  Patients with other coagulation dysfunction diseases in addition to hemophilia A;

          -  Patients who used any anticoagulant or anti-platelet treatment (including
             non-steroidal anti-inflammatory drugs [NSAIDs]) within 1 weeks before the first drug
             administration or who regularly (e.g., daily, every other day) use anticoagulant or
             anti-platelet treatment within the clinical trial period;

          -  Patients who used immunomodulator(e.g., immunoglobulin,
             corticosteroids,alpha-interferon, prednisone [>10 mg/day and >7 days], or comparable
             drugs, other than anti-retroviral chemotherapy) within two weeks before the first
             administration of the study drug or during the clinical trial period;

          -  Administration of any cryoprecipitate, whole blood or plasma within 30 days prior to
             administration of study drug.

          -  Patients with other clinically significant diseases, alcoholism, drug abuse, mental
             disorders or intellectual disabilities;

          -  Patients with other severe or clinical significant diseases verified by the
             investigator to be unable to benefit from the clinical study;

          -  Patients who participated in other clinical studies within one month before the first
             drug administration (except FVIII trials) and patients who participated in other FVIII
             clinical trials after signing the Informed Consent Form;
Male
No healthy subjects accepted to join the trial.

Subject must be at most 12 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