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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano, Italy, 20122 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum AKH Wien Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eulji University Hospital Daejeon, South Korea, 35233 | Status Completed | Contact Us: E-mail: c[email protected] Phone: (+)1-888-84 22937 |
Locations Pecsi Tudomanyegyetem Klinikai Kozpont Pecs, Hungary, 7624 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Hospital of Wales Cardiff, United Kingdom, CF14 4XW | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Manchester Royal Infirmary Manchester, United Kingdom, M13 9WL | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Free Hospital London, United Kingdom, NW3 2QG | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fiona Stanley Hospital Murdoch, Australia, 6150 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD Sofia, Bulgaria, 1756 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Sveta Marina EAD Varna, Bulgaria, 9010 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ogikubo Hospital Suginami, Japan, 167-0035 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hiroshima University Hospital Hiroshima, Japan, 734-8551 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical centre Hipokrat - N EOOD Plovdiv, Bulgaria, 4000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Haematology Service, Canterbury Health Laboratories Christchurch, New Zealand, 8011 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Robert Debré - Reims Cedex REIMS CEDEX, France, 51092 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Louis Pradel - Bron BRON, France, 69500 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Changhua Christian Hospital Changhua, Taiwan, China, 50006 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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
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.Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: 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
Additional Information
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