Last updated on July 2019

Multiple Escalating Dose Study of BAY1093884 in Adults With Hemophilia A or B With or Without Inhibitors

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hemophilia A and B
  • Age: Between 18 - 100 Years
  • Gender: Male

Inclusion Criteria:

  • Male severe hemophilic patients with undetectable FVIII activity <1% or FIX activity <2%, with or without inhibitors (any titer) are eligible.
  • Subjects with a past history of inhibitors (any inhibitor titer) are eligible.
  • Age 18 years.
  • Documentation of 4 bleeding episodes (any type or location of bleeds, treated or not) within the 6 months prior to screening.
  • For subjects on prophylaxis: Willingness to interrupt ongoing prophylaxis.
  • For subjects on immune tolerance induction (ITI): Willingness to interrupt ongoing ITI.

Exclusion Criteria:

  • History of any other coagulation disorder (particularly disseminated intravascular coagulopathy or combined FVIII/FV deficiency) or platelet disorder.
  • History of diseases related to venous thromboembolic events (e.g., pulmonary embolism, deep vein thrombosis, thrombophlebitis) or thrombotic microangiopathy.
  • Risk factors for venous or arterial diseases (e.g., uncontrolled hypertension, uncontrolled diabetes).
  • History of cardiac, coronary and/or arterial peripheral atherosclerotic disease
  • Platelet count <100,000/L.
  • Human immunodeficiency virus (HIV) infection with a cluster of differentiation 4 (CD4+) lymphocyte count of <200/mm3

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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