Clinical trial: An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A (NCT01486927)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosis of severe hemophilia A defined as <1% FVIII:C documented in medical records.

          -  Males between 18 and 65 years of age (Parts 1 and 2).

          -  Males between 12 and 65 years of age (Part 3).

          -  Subjects who have received or are currently receiving FVIII products (plasma-derived
             and/or recombinant FVIII) and have had >150 exposure days (EDs) with a FVIII product

          -  Written informed consent for study participation obtained before undergoing any study
             specific procedures.

        Exclusion Criteria:

          -  Any history of or current FVIII inhibitors

          -  Any first order family history of FVIII inhibitors

          -  Use of an Investigational Medicinal Product within 30 days prior to the first
             rVIII-SingleChain administration.

          -  Administration of any cryoprecipitate, whole blood or plasma within 30 days prior to
             administration of rVIII-SingleChain or reference product.

          -  Known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII product or
             hamster protein.

          -  Any known congenital or acquired coagulation disorder other than congenital FVIII
             deficiency.

          -  Platelet count < 100,000/µL at screening.

          -  Human immunodeficiency virus (HIV) positive subjects with a CD4 count < 200/mm3, in
             their medical history or at screening if available results are older than one year.
             (HIV positive subjects may participate in the study and antiviral therapy are
             permitted, at the discretion of the Investigator).

          -  Subject currently receiving IV immunomodulating agents such as immunoglobulin or
             chronic systemic corticosteroid treatment.

          -  Subject with serum aspartate aminotransferase (AST) or serum alanine aminotransferase
             (ALT) values > 5 times (x) the upper limit of normal (ULN) at Screening.

          -  Subjects with serum creatinine values > 2 x ULN at Screening.

          -  Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism,
             myocardial infarction and arterial embolus within 3 months prior to Day 1.

          -  Experienced life-threatening bleeding episode or had major surgery or an orthopedic
             surgical procedure during the 3 months prior to Day 1.
Male
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