Trial Condition(s):
Study to test the safety of an investigational drug given repeatedly to adult men with severe hemophilia
The purpose of this study is to investigate the safety of a test drug to treat hemophilia in adult men.
- Participants with hemophilia A and FVIII activity <1% or hemophilia B with FIX activity <2% - Participants must be currently without inhibitors or with low titer inhibitors (inhibitor titer < 5 Bethesda units) who are receiving current on demand treatment with any FVIII or FIX (recombinant or plasma-derived; modified or unmodified)
- History or at risk of developing diseases related to venous thromboembolic events (e.g., pulmonary embolism, deep vein thrombosis or thrombophlebitis) - History of any other clinically relevant coagulation disorder (particularly disseminated intravascular coagulopathy or combined FVIII/Factor V deficiency) or platelet disorder - History or at risk of developing cardiac, coronary and/or arterial peripheral atherosclerotic disease and/or arterial thromboembolic events, particularly myocardial infarction, cerebrovascular accident, stroke, transient ischemic attack, congestive heart failure, angina pectoris, treatment for angina pectoris or uncontrolled hypertension - History or at risk for thrombotic microangiopathy
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A multicenter, non-randomized, open-label, multiple dose escalation study to evaluate the safety and tolerability of subcutaneous BAY1093884 in males with severe hemophilia
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
N/A
Blinding:
N/A
Assignment:
Sequential Assignment
Trial Arms:
1
Not Available