Clinical trial: Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980 (NCT00629837)

Eligibility criteria:
Inclusion Criteria:

          -  Males aged 12 to 60 years

          -  Hemophilia A with plasma FVIII level less than 1% (severe hemophilia)

          -  No history of FVIII inhibitor antibody formation and no current evidence of inhibitor
             antibody measured using the Nijmegen modified Bethesda assay (< 0.6 Nijmegen Bethesda
             Units [N.B.U.]/mL)

          -  No signs or symptoms of an acute bleeding episode on the day of infusion

          -  Four or more days without treatment with FVIII prior to the day of infusion

          -  Subject (or the subject's legal representative) must provide written informed consent
             and authorization of use and disclosure of Protected Health Information (PHI)

          -  Subjects must have been previously treated with FVIII concentrate for a total of at
             least 200 exposure days, including 20 exposure days in the previous 12 months.
             Previous treatment can have been with any type of rFVIII or plasma-derived FVIII
             concentrate

        Exclusion Criteria:

          -  Individuals with abnormal renal function (serum creatinine concentrations greater than
             1.3 mg/dL) or active hepatic disease (persistent aspartate aminotransferase [AST] or
             alanine aminotransferase [ALT] increases to greater than five times the upper limit of
             normal).

          -  Individuals with anemia, as defined by hemoglobin level less than 12 g/dL

          -  Any individual with a past history of severe reaction(s) to FVIII products

          -  Any individual on interferon treatment or who has received interferon within the
             previous 3 months

          -  Any individual with thrombocytopenia (platelets greater than or equal to 100,000
             cells/mm3) or known hematologic/bleeding problems other than hemophilia A

          -  Any individual who is receiving or has received other experimental drugs within 3
             months prior to study entry

          -  Any individual with known dislipidemic disease or actively taking cholesterol lowering
             drugs for the treatment of hypercholesterolemia or hyperlipidemia (e.g., statins,
             cholesterol absorption inhibitors, bile acid sequestrants, nicotinic acid or fibrates)
             or individuals taking anaesthetic drugs

          -  Any individual who requires pre-medication for FVIII infusions (e.g., antihistamines)

          -  Any individual with high blood pressure (defined as diastolic blood pressure great
             than or equal to 100 mm/Hg)

          -  Any patient who cannot forego FVIII treatment for at least 4 days prior to study entry
             or between study infusions due to a need for more frequent prophylactic treatment
             because of a pre-existing medical condition

          -  Any patient with known allergy or severe reactions to liposomes or PEG

          -  Individuals with any other known disease affecting hemostasis besides hemophilia A

          -  Any patient who is not suitable for participation in this trial for any reason,
             according to the Investigator
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? Entailment