Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety of a test drug to treat hemophilia in adult men.

Detailed Description
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The primary objective is to assess the safety of multiple doses of BAY1093884.

Official Title
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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

Conditions
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Hemophilia

Intervention / Treatment
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* Drug: BAY1093884


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemophilia<br>Dose escalation starting with 200 mg of BAY1093884 | Drug: BAY1093884<br>* Drug administered via subcutaneous injections once weekly for 6 weeks (= 6 doses)<br>* Other names: Human monoclonal immunoglobulin G2 antibody blocking the endogenous tissue factor pathway inhibitor (TFPI);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of drug-related adverse events |  | Up to 3 months | 
| Frequency of drug-related serious adverse events |  | Up to 3 months | 
| Frequency of adverse events of special interest | Adverse events of special interest comprise thromboembolic and thrombotic microangiopathy events, and hypersensitivity reactions. | Up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coagulation Factor VIII (FVIII), Coagulation Factor IX (FIX), Anti-tissue factor pathway inhibitor (aTFPI), Human monoclonal immunoglobulin G2 antibody