Clinical trial: Phase 3 Efficacy and Safety Study of BAX 855 in Severe Hemophilia A Patients Undergoing Surgical Procedures (NCT01913405)

Eligibility criteria:
Inclusion Criteria:

          -  Participant requires an elective major or minor surgical, dental or other invasive
             procedure (e.g. biopsy, endoscopy).

          -  Participant and/or legal representative has/have provided signed informed consent.

          -  Participant has severe hemophilia A (Factor VIII (FVIII) level <1%) as confirmed by
             the central lab at screening or a documented FVIII activity level <1%.

          -  Participant was previously treated with FVIII concentrates with ≥150 documented
             exposure days (EDs).

          -  Participant is currently receiving prophylaxis or on-demand therapy with FVIII
             concentrate.

          -  Participant has a Karnofsky performance score of ≥60 at screening.

          -  Participant is human immunodeficiency virus negative (HIV-); or HIV+ with stable
             disease and CD4+ count ≥200 cells/mm^3, as confirmed by central laboratory at
             screening.

          -  Participant is Hepatitis C virus negative (HCV-) by antibody or PCR testing (if
             positive, antibody titer will be confirmed by PCR), as confirmed by central laboratory
             at screening; or HCV+ with chronic stable hepatitis as assessed by the investigator.

          -  Participant is willing and able to comply with the requirements of the study protocol.

        Exclusion Criteria:

          -  Participant has detectable FVIII inhibitory antibodies (≥0.4 Bethesda Unit (BU) using
             the Nijmegen modification of the Bethesda assay) at screening as determined by the
             central laboratory or at any timepoint prior to screening (≥0.4 BU using the Nijmegen
             modification of the Bethesda assay or ≥0.6 BU using the Bethesda assay).

          -  History of ongoing or recent thrombotic disease, fibrinolysis or disseminated
             intravascular coagulation (DIC).

          -  Participant has a platelet count <100 x 10^9/L, as confirmed by central laboratory at
             screening.

          -  Participant has severe renal impairment (serum creatinine > 2.0 mg/dL), as confirmed
             by central laboratory at screening.

          -  Participant has severe chronic hepatic dysfunction (eg ≥5 X upper limit of normal
             alanine aminotransferase (ALT), as confirmed by the central laboratory at screening,
             or a documented International Normalized Ratio (INR) > 1.5).

          -  Participant has a known hypersensitivity towards mouse or hamster proteins,
             polysorbate 80 or to PEG.

          -  Participant is currently using or has recently (< 30 days) used pegylated drugs (other
             than BAX 855) prior to study participation or is scheduled to use such drugs during
             trial participation.

          -  Participant is currently participating in another clinical drug (other than BAX 855)
             or device study or use of another investigational product or device within 30 days
             prior to study entry.

          -  Participant has a diagnosis of an inherited or acquired hemostatic defect other than
             hemophilia A.

          -  Participant is currently receiving, or scheduled to receive during the course of the
             study, an immunomodulating drug (eg, systemic corticosteroid agent at a dose
             equivalent to hydrocortisone >10 mg/day, or alpha interferon) other than
             anti-retroviral chemotherapy.

          -  Participant has a clinically significant medical, psychiatric, or cognitive illness,
             or recreational drug/alcohol use that, in the opinion of the investigator, would
             affect participant safety or compliance.
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? 0