Trial Condition(s):
Hemophilia
Study to test the safety of an investigational drug given repeatedly to adult men with severe hemophilia
Bayer Identifier:
20414
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Terminated/Withdrawn
Trial Purpose
The purpose of this study is to investigate the safety of a test drug to treat hemophilia in adult men.
Inclusion Criteria
- 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)Exclusion Criteria
- 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 microangiopathyTrial Summary
Enrollment Goal
0
Trial Dates
Phase
1
Could I receive a placebo?
No
Products
BAY1093884
Accepts Healthy Volunteers
No
Where to Participate
Locations
Status
| Locations | Status |
|---|
Trial Design
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
Primary Outcome
- Frequency of drug-related adverse eventsTimeframe: Up to 3 months
- Frequency of drug-related serious adverse eventsTimeframe: Up to 3 months
- Frequency of adverse events of special interestAdverse events of special interest comprise thromboembolic and thrombotic microangiopathy events, and hypersensitivity reactions.Timeframe: Up to 3 months
Additional Information
Not Available
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