Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia
NCT ID: NCT03996486
Last Updated: 2019-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2019-10-28
2020-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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SEQUENTIAL
OTHER
NONE
Study Groups
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Hemophilia
Dose escalation starting with 200 mg of BAY1093884
BAY1093884
Drug administered via subcutaneous injections once weekly for 6 weeks (= 6 doses)
Interventions
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BAY1093884
Drug administered via subcutaneous injections once weekly for 6 weeks (= 6 doses)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Other Identifiers
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2018-004566-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20414
Identifier Type: -
Identifier Source: org_study_id
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