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:

NCT03996486

EudraCT Number:

2018-004566-34

Terminated/Withdrawn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 microangiopathy

Trial Summary

Enrollment Goal
0
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
BAY1093884
Accepts Healthy Volunteers
No

Where to Participate

Locations
Status
LocationsStatus

Trial Design