Trial Condition(s):

Hemophilia A and B

Multiple escalating dose study of BAY1093884 in adults with hemophilia A or B with or without inhibitors

Bayer Identifier:

19580

ClinicalTrials.gov Identifier:

NCT03597022

EudraCT Number:

2017-003324-67

Terminated/Withdrawn

Trial Purpose

The purpose of this study was to assess the safety and tolerability of multiple doses of a human monoclonal antibody (BAY1093884) given under the skin in subjects with hemophilia A or B. This antibody was intended to protect from bleeds by inhibiting a substance (Tissue Factor Pathway Inhibitor, TFPI) that reduces the ability of the body to form blood clots.

Inclusion Criteria
- Male severe hemophilic patients with undetectable FVIII activity <1% or FIX activity <2%, with or without inhibitors (any titer) are eligible.
- 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 any other coagulation disorder (particularly disseminated intravascular coagulopathy or combined FVIII/FV deficiency) or platelet disorder.
- 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

Trial Summary

Enrollment Goal
24
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
BAY1093884
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

Status
Completed
 
Locations

Universitätsklinikum AKH Wien

Wien, Austria, 1090

Status
Completed
 
Locations

Eulji University Hospital

Daejeon, South Korea, 35233

Status
Completed
 
Locations

Pecsi Tudomanyegyetem Klinikai Kozpont

Pecs, Hungary, 7624

Status
Completed
 
Locations

University Hospital of Wales

Cardiff, United Kingdom, CF14 4XW

Status
Completed
 
Locations

Manchester Royal Infirmary

Manchester, United Kingdom, M13 9WL

Status
Completed
 
Locations

Royal Free Hospital

London, United Kingdom, NW3 2QG

Status
Completed
 
Locations

Fiona Stanley Hospital

Murdoch, Australia, 6150

Status
Completed
 
Locations

SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD

Sofia, Bulgaria, 1756

Status
Completed
 
Locations

MHAT Sveta Marina EAD

Varna, Bulgaria, 9010

Status
Completed
 
Locations

Ogikubo Hospital

Suginami, Japan, 167-0035

Status
Completed
 
Locations

Hiroshima University Hospital

Hiroshima, Japan, 734-8551

Status
Completed
 
Locations

Medical centre Hipokrat - N EOOD

Plovdiv, Bulgaria, 4000

Status
Completed
 
Locations

Haematology Service, Canterbury Health Laboratories

Christchurch, New Zealand, 8011

Status
Completed
 
Locations

Hôpital Robert Debré - Reims Cedex

REIMS CEDEX, France, 51092

Status
Completed
 
Locations

Hôpital Louis Pradel - Bron

BRON, France, 69500

Status
Completed
 
Locations

Changhua Christian Hospital

Changhua, Taiwan, China, 50006

Status
Completed
 

Trial Design