stop_circleTerminated/Withdrawn
Hemophilia A and B
Bayer Identifier:
19580
ClinicalTrials.gov Identifier:
EudraCT Number:
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
MaleAge
18 - N/ATrial summary
Enrollment Goal
24Trial Dates
July 2018 - October 2019Phase
Phase 2Could I Receive a placebo
NoProducts
BAY1093884Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milano, 20122, Italy |
Withdrawn | ULSS8 Berica | Vicenza, 36100, Italy |
Withdrawn | A.O.U. Città della Salute e della Scienza di Torino | Torino, 10126, Italy |
Completed | Universitätsklinikum AKH Wien | Wien, 1090, Austria |
Completed | Eulji University Hospital | Daejeon, 35233, Korea, Republic Of |
Completed | Pecsi Tudomanyegyetem Klinikai Kozpont | Pecs, 7624, Hungary |
Completed | University Hospital of Wales | Cardiff, CF14 4XW, United Kingdom |
Completed | Manchester Royal Infirmary | Manchester, M13 9WL, United Kingdom |
Completed | Royal Free Hospital | London, NW3 2QG, United Kingdom |
Completed | Fiona Stanley Hospital | Murdoch, 6150, Australia |
Completed | SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD | Sofia, 1756, Bulgaria |
Completed | MHAT Sveta Marina EAD | Varna, 9010, Bulgaria |
Withdrawn | Kent & Canterbury Hospital | Canterbury, CT1 3NG, United Kingdom |
Completed | Ogikubo Hospital | Suginami, 167-0035, Japan |
Completed | Hiroshima University Hospital | Hiroshima, 734-8551, Japan |
Completed | Medical centre Hipokrat - N EOOD | Plovdiv, 4000, Bulgaria |
Withdrawn | Hopital Necker les enfants malades - Paris | PARIS, 75015, France |
Completed | Haematology Service, Canterbury Health Laboratories | Christchurch, 8011, New Zealand |
Completed | Hôpital Robert Debré - Reims Cedex | REIMS CEDEX, 51092, France |
Completed | Hôpital Louis Pradel - Bron | BRON, 69500, France |
Withdrawn | National Taiwan University Hospital | Taipei, 10016, Taiwan |
Withdrawn | Far Eastern Memorial Hospital | New Taipei City, 220, Taiwan |
Withdrawn | Taipei Medical University Hospital | Taipei, 110, Taiwan |
Completed | Changhua Christian Hospital | Changhua, 50006, Taiwan |
Withdrawn | China Medical University Hospital | Taichung, 40447, Taiwan |
Primary Outcome
- Number of participants with drug-related treatment-emergent adverse eventsAn 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 eventsA 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 interestAny 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
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
N/AAssignment
Sequential AssignmentTrial Arms
3