Clinical trial: Study of Recombinant Human Coagulation Factor VIIa for Injection (FⅦa) in Patients With Hemophilia. (NCT04768699)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosed as congenital hemophilia A or B, and meet the following conditions: a. FⅧ<1%
             or FIX activity<2%; b. FⅧ inhibitor or FⅨ inhibitor titer in the screening period>5 BU
             (Nijmegen modified Bethesda method of detection).

          -  Age ≥18 and ≤75 years, male or female.

          -  No other drugs for the treatment of hemophilia have been used within 48 hours (2 days)
             before administration, including prothrombin complex and any FVII products,
             cryoprecipitate, fresh plasma and whole blood, etc.

          -  No obvious bleeding symptoms during PK medication (no active bleeding).

          -  Subjects of childbearing age agree to take effective contraceptive measures throughout
             the trial period, and continue to 28 days after the last medication.

          -  Volunteer to participate in this study, sign an informed consent form, have good
             compliance, and be able to cooperate with the experimental observation.

        Exclusion Criteria:

          -  Any other bleeding disease except Congenital hemophilia A or B.

          -  Patients with any previous medical history or symptoms of arterial or venous
             thromboembolic events (such as atherosclerosis, myocardial infarction, ischemic
             stroke, transient ischemic attack, deep vein thrombosis or pulmonary hypertension
             embolism) or disseminated intravascular coagulation (DIC).

          -  Baseline and previous values of FⅦ inhibitor or rFVIIa inhibitor is positive.

          -  Vitamin K deficiency.

          -  Human immunodeficiency virus (HIV) positive and cluster of differentiation 4 (CD4)
             count ≤200/μl, the number of virus carriers ≥200 particles/μl or ≥400000 copies/ml.

          -  Subjects plan to perform elective surgery during the trial period.

          -  Those who are allergic to test drugs or any excipients.

          -  Severe anemia and need blood transfusion.

          -  Platelet count <80×10^9/L.

          -  Obvious liver or kidney damage: ALT or AST>2.5×ULN, or total bilirubin>1.5×ULN or
             serum creatinine>1.5×ULN.

          -  Have a history of cardiac surgery and need anticoagulation therapy; severe heart
             disease, including myocardial infarction, cardiac insufficiency grade 3 or above, the
             current New York Heart Association cardiac function grade II-IV.

          -  Hypertension that cannot be controlled with drug treatment: systolic blood pressure>
             150 mmHg or diastolic blood pressure> 90 mmHg.

          -  Participated in other clinical studies (except FVIIa, FⅧ and FⅨ trials) within one
             month before the first medication.

          -  Diagnosed with hereditary diseases such as fructose intolerance, glucose malabsorption
             or sucrose-maltase deficiency.

          -  Alcoholism, drug abuse, mental disorders, other severe acute or chronic diseases,
             greater abnormal laboratory values, and those who are considered unsuitable by the
             researcher.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 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