Brief Title
Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia
Official Title
A Multicenter, Non-randomized, Open-label, Multiple Dose Escalation Study to Evaluate the Safety and Tolerability of Subcutaneous BAY1093884 in Males With Severe Hemophilia
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 Phase
Phase 1
Study Type
Interventional
Primary Outcome
Frequency of drug-related adverse events
Condition
Hemophilia
Intervention
BAY1093884
Study Arms / Comparison Groups
Hemophilia
Description: Dose escalation starting with 200 mg of BAY1093884
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
October 28, 2019
Completion Date
July 31, 2020
Primary Completion Date
May 29, 2020
Eligibility Criteria
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
Gender
Male
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
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Administrative Informations
NCT ID
NCT03996486
Organization ID
20414
Secondary IDs
2018-004566-34
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
, ,
Verification Date
October 2019