NCT03996486WithdrawnPhase 1
A Multicenter, Non-randomized, Open-label, Multiple Dose Escalation Study to Evaluate the Safety and Tolerability of Subcutaneous BAY1093884 in Males With Severe Hemophilia
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Bayer
- Primary Endpoint
- Frequency of drug-related adverse events
Study Overview
Brief Summary
The purpose of this study is to investigate the safety of a test drug to treat hemophilia in adult men.
Detailed Description
The primary objective is to assess the safety of multiple doses of BAY1093884.
Study Design
- Study Type
- Interventional
- Intervention Model
- Sequential
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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 microangiopathy
Arms & Interventions
Hemophilia
Experimental
Dose escalation starting with 200 mg of BAY1093884
Intervention: BAY1093884 (Drug)
Outcomes
Primary Outcomes
Frequency of drug-related adverse events
Time Frame: Up to 3 months
Frequency of drug-related serious adverse events
Time Frame: Up to 3 months
Frequency of adverse events of special interest
Time Frame: Up to 3 months
Adverse events of special interest comprise thromboembolic and thrombotic microangiopathy events, and hypersensitivity reactions.
Secondary Outcomes
No secondary outcomes reported
Investigators
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