Multiple Escalating Dose Study of BAY1093884 in Adults With Hemophilia A or B With or Without Inhibitors
NCT ID: NCT03597022
Last Updated: 2020-11-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
24 participants
INTERVENTIONAL
2018-07-24
2019-10-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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BAY1093884 100mg
Subjects received BAY1093884 100 mg once a week until premature termination of the study
Befovacimab (BAY1093884)
Once weekly doses until premature termination of the study, subcutaneous injection
BAY1093884 225mg
Subjects received BAY1093884 225 mg once a week until premature termination of the study
Befovacimab (BAY1093884)
Once weekly doses until premature termination of the study, subcutaneous injection
BAY1093884 400mg
Subjects received BAY1093884 400mg once a week until premature termination of the study
Befovacimab (BAY1093884)
Once weekly doses until premature termination of the study, subcutaneous injection
Interventions
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Befovacimab (BAY1093884)
Once weekly doses until premature termination of the study, subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with a past history of inhibitors (any inhibitor titer) are eligible.
* Age ≥18 years.
* Documentation of ≥4 bleeding episodes (any type or location of bleeds, treated or not) within the 6 months prior to screening.
* For subjects on prophylaxis: Willingness to interrupt ongoing prophylaxis.
* For subjects on immune tolerance induction (ITI): Willingness to interrupt ongoing ITI.
Exclusion Criteria
* History of diseases related to venous thromboembolic events (e.g., pulmonary embolism, deep vein thrombosis, thrombophlebitis) or thrombotic microangiopathy.
* Risk factors for venous or arterial diseases (e.g., uncontrolled hypertension, uncontrolled diabetes).
* History of cardiac, coronary and/or arterial peripheral atherosclerotic disease
* Platelet count \<100,000/μL.
* Human immunodeficiency virus (HIV) infection with a cluster of differentiation 4 (CD4+) lymphocyte count of \<200/mm\^3
18 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Universitätsklinikum AKH Wien
Vienna, , Austria
Medical centre Hipokrat - N EOOD
Plovdiv, , Bulgaria
SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD
Sofia, , Bulgaria
MHAT Sveta Marina EAD
Varna, , Bulgaria
Hôpital Louis Pradel - Bron
Bron, , France
Hôpital Robert Debré - Reims Cedex
Reims, , France
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, , Hungary
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
Ogikubo Hospital
Suginami, Tokyo, Japan
Hiroshima University Hospital
Hiroshima, , Japan
Haematology Service, Canterbury Health Laboratories
Christchurch, , New Zealand
Eulji University Hospital
Daejeon, , South Korea
Changhua Christian Hospital
Changhua, , Taiwan
University Hospital of Wales
Cardiff, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here to find results for studies related to Bayer products
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2017-003324-67
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
19580
Identifier Type: -
Identifier Source: org_study_id