Clinical trial: A Phase I Safety, Pharmacokinetics and Pharmacodynamics Study of Recombinant Factor VIIa in Adult Patients With Hemophilia A or B (NCT01708564)

Eligibility criteria:
Inclusion Criteria:

          1. be male with a diagnosis of moderate or severe congenital hemophilia A and/or B (with
             or without inhibitors)

          2. be 18 years or older, up to and including 75 years of age

          3. be capable of understanding and willing to comply with the conditions of the protocol

          4. have read, understood and provided written informed consent

        Exclusion Criteria:

          1. have any coagulation disorder other than hemophilia A or B

          2. have a body weight >105 kg (231 lb)

          3. be immuno-suppressed (i.e., the patient should not receive systemic immunosuppressive
             medication <30 days prior to enrollment, CD4 counts at screening should be >200/µl)

          4. have a known allergy or hypersensitivity to rabbits

          5. have platelet count <100,000/mL

          6. have had within one month prior to first administration of the study drug in this
             study a major surgical procedure (e.g. orthopedic, abdominal)

          7. have an active, ongoing bleeding for which the patient is being treated, or treatment
             for a bleeding was stopped within 24 hours of the time of study drug administration

          8. have received a Factor VII or FVIIa containing product (either plasma derived or
             recombinant) within 72 hours prior to any study drug administration

          9. have received an investigational drug within 30 days of the first study drug
             administration, or is expected to receive such drug during participation in this study

         10. have a clinically relevant hepatic (hepatic enzymes >3 times the upper limit of
             normal) and/or renal impairment (creatinine >2 times the upper limit of normal)

         11. have a history of arterial and/or venous thromboembolic events (such as myocardial
             infarction, ischemic strokes, transient ischemic attacks, deep venous thrombosis or
             pulmonary embolism) within 2 years prior to first dose of study drug, have an arterial
             stent in place or have clinically significant atherosclerotic disease (e.g., angina
             pectoris, peripheral vascular disease)

         12. use any anticoagulant for arterial/venous obstructions and/or atrial fibrillation
             within 7 days prior to first study drug administration

         13. have an active malignancy (those with non-melanoma skin cancer are allowed)

         14. have any life-threatening disease or other disease or condition which, according to
             the investigator's judgment, could imply a potential hazard to the patient, interfere
             with the trial participation or trial outcome
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 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? 1