stop_circleTerminated/Withdrawn

Hemophilia A and B

Bayer Identifier:

19580

ClinicalTrials.gov Identifier:

NCT03597022

EudraCT Number:

2017-003324-67

EU CT Number:

Not Available
Multiple escalating dose study of BAY1093884 in adults with hemophilia A or B with or without inhibitors

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - 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.
  • - 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
July 2018 - October 2019
Phase
Phase 2
Could I Receive a placebo
No
Products
BAY1093884
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoMilano, 20122, Italy
Withdrawn
ULSS8 BericaVicenza, 36100, Italy
Withdrawn
A.O.U. Città della Salute e della Scienza di TorinoTorino, 10126, Italy
Completed
Universitätsklinikum AKH WienWien, 1090, Austria
Completed
Eulji University HospitalDaejeon, 35233, Korea, Republic Of
Completed
Pecsi Tudomanyegyetem Klinikai KozpontPecs, 7624, Hungary
Completed
University Hospital of WalesCardiff, CF14 4XW, United Kingdom
Completed
Manchester Royal InfirmaryManchester, M13 9WL, United Kingdom
Completed
Royal Free HospitalLondon, NW3 2QG, United Kingdom
Completed
Fiona Stanley HospitalMurdoch, 6150, Australia
Completed
SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EADSofia, 1756, Bulgaria
Completed
MHAT Sveta Marina EADVarna, 9010, Bulgaria
Withdrawn
Kent & Canterbury HospitalCanterbury, CT1 3NG, United Kingdom
Completed
Ogikubo HospitalSuginami, 167-0035, Japan
Completed
Hiroshima University HospitalHiroshima, 734-8551, Japan
Completed
Medical centre Hipokrat - N EOODPlovdiv, 4000, Bulgaria
Withdrawn
Hopital Necker les enfants malades - ParisPARIS, 75015, France
Completed
Haematology Service, Canterbury Health LaboratoriesChristchurch, 8011, New Zealand
Completed
Hôpital Robert Debré - Reims CedexREIMS CEDEX, 51092, France
Completed
Hôpital Louis Pradel - BronBRON, 69500, France
Withdrawn
National Taiwan University HospitalTaipei, 10016, Taiwan
Withdrawn
Far Eastern Memorial HospitalNew Taipei City, 220, Taiwan
Withdrawn
Taipei Medical University HospitalTaipei, 110, Taiwan
Completed
Changhua Christian HospitalChanghua, 50006, Taiwan
Withdrawn
China Medical University HospitalTaichung, 40447, Taiwan

Primary Outcome

  • Number of participants with drug-related treatment-emergent adverse events
    An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant in the study. Any bleeding event occurring during the study was not documented as an AE because this event was planned to be captured in the assessment of efficacy. AEs occurring after the first administration of study drug and up to and including 30 days after the last administration of study drug were defined as treatment-emergent AEs (TEAEs). Drug-related TEAEs were TEAEs that had "reasonable causal relationship" to the study treatment decided by the investigators.
    date_rangeTime Frame:
    After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
  • Number of participants with serious treatment-emergent adverse events
    A serious adverse event (SAE) was any untoward medical occurrence that at any dose was resulting in death, was lifethreatening, requires hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity. SAEs occurring after the first administration of study drug and up to and including 30 days after the last administration of study drug were defined as serious treatment-emergent AEs (TESAEs). Drug-related TESAEs were TESAEs that had "reasonable causal relationship" to the study treatment decided by the investigators.
    date_rangeTime Frame:
    After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
  • Number of participants with treatment-emergent adverse events of special interest
    Any thromboembolic or thrombotic microangiopathic event or any hypersensitivity reaction was an adverse event of special interest (AESI). AESIs occurring after the first administration of study drug and up to and including 30 days after the last administration of study drug were defined as treatment-emergent AESIs.
    date_rangeTime Frame:
    After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
  • Number of participants with clinically relevant abnormalities in laboratory values
    “Clinically relevant “implied the presence of a clinical sign or symptom that required medical action.
    date_rangeTime Frame:
    After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days

Trial design

Multiple escalating dose study of BAY1093884 in adults with hemophilia A or B with or without inhibitors
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
N/A
Assignment
Sequential Assignment
Trial Arms
3

Additional Information

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