Clinical trial: An Open Label Study to Determine the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A. (NCT04456387)

Eligibility criteria:
Inclusion Criteria:

          -  1)Male, aged 12 to 60 years

          -  2)Severe hemophilia A. The activity of the coagulation factor VIII (FVIII:C) < 1%, and
             previously treated with FVIII concentrate (s) for a minimum of 150 exposure days (EDs)
             prior to study entry.

          -  3) No history of a positive inhibitor test (< 0.6 BU) or clinical signs of decreased
             response to FVIII administrations within 2 years before the test or during the
             screening period. No Family history of inhibitors.

          -  4) Non-immune deficiency, with a certain immune capacity (CD4 > 200/μL)

          -  5) Platelet count > 100,000 platelets/μL.

          -  6) Normal prothrombin time or INR < 1.3.

          -  7) Normal previous results of vWF antigen examination.

          -  8) Negative lupus anticoagulant.

          -  9) the patient has a detailed record of bleeding events for at least 6 months (the
             subject can be admitted to the on-demand treatment group with spontaneous bleeding ≥3
             times within 6 months).

          -  10) Capable of understanding and willing to comply with the conditions of the protocol
             have read (patient and/or guardian).

        Exclusion Criteria:

          -  1) Hypersensitive to any of the excipients of the test materials (e.g. allergic to
             murine or hamster origin heterologous proteins).

          -  2) History of hypersensitivity or anaphylaxis associated with any FVIII or II
             immunoglobulin administration.

          -  3) Other coagulation disorder(s) in addition to hemophilia A.

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

          -  5) Clinically significant of other systematic diseases: alcoholism, drug abuse, mental
             disorders and mental retardation.

          -  6) Significant hepatic or renal impairment (ALT and AST > 2×ULN; serum bilirubin level
             > 3 × upper limit of normal (ULN), BUN > 2×ULN, Cr > 176.8µmol/L).

          -  7) Patients who received any anticoagulant or antiplatelet therapy within one week
             prior screening or need to receive an anticoagulant or antiplatelet therapy during the
             period of clinical trials.

          -  8) Patients having major surgery or receiving blood or blood components transfusion
             within 4 weeks prior screening or having planned major surgery schedule during the
             study.

          -  9) Patients who previously participated in the other clinical trials within 1 month
             prior screening.

          -  10) One or more clinically significant tests for Hepatitis B Virus Surface Antigen,
             Human Immunodeficiency Virus (HIV), Antisyphilitic spirulina (TPHA) and Hepatitis C
             Virus (HCV) Antibody.

          -  11) Any life-threatening disease or condition which, according to the investigator's
             judgment, could not benefit from the trial participation.

          -  12) Patient who is considered by the other investigators not suitable for clinical
             study.

        NOTE:Other protocol-defined Inclusion/Exclusion criteria may apply.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 60 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? 0