Trial Condition(s):
Study to test the safety of an investigational drug given repeatedly to adult men with severe hemophilia
20414
Not Available
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
Locations | Status |
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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