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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003324-67 | EudraCT Number |
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Due to thrombosis
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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.
The primary objective of the study was to assess the safety and tolerability of multiple subcutaneous injections of BAY1093884 (anti-TFPI monoclonal antibody, immunoglobulin G2, IgG2) in patients with hemophilia A or B with or without inhibitors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY1093884 100mg | Experimental | Subjects received BAY1093884 100 mg once a week until premature termination of the study |
|
| BAY1093884 225mg | Experimental | Subjects received BAY1093884 225 mg once a week until premature termination of the study |
|
| BAY1093884 400mg | Experimental | Subjects received BAY1093884 400mg once a week until premature termination of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Befovacimab (BAY1093884) | Drug | Once weekly doses until premature termination of the study, subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fiona Stanley Hospital | Murdoch | Western Australia | 6150 | Australia | ||
| Universitätsklinikum AKH Wien |
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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Overall, 26 participants were screened. Of them, 1 participant was screen failure and 1 participant could not start subsequent treatment on schedule; 24 participants received study treatment.
Study was conducted at multiple centers in 11 countries or regions between 24 July 2018 (first subject first visit) and 15 October 2019 (last subject last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | BAY1093884 100mg | Subjects received BAY1093884 100 mg once a week until premature termination of the study |
| FG001 | BAY1093884 225mg | Subjects received BAY1093884 225 mg once a week until premature termination of the study |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 5, 2019 | Oct 13, 2020 |
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|
| 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. | 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 |
| Vienna |
| 1090 |
| Austria |
| Medical centre Hipokrat - N EOOD | Plovdiv | 4000 | Bulgaria |
| SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD | Sofia | 1756 | Bulgaria |
| MHAT Sveta Marina EAD | Varna | 9010 | Bulgaria |
| Hôpital Louis Pradel - Bron | Bron | 69500 | France |
| Hôpital Robert Debré - Reims Cedex | Reims | 51092 | France |
| Pecsi Tudomanyegyetem Klinikai Kozpont | Pécs | 7624 | Hungary |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | Lombardy | 20122 | Italy |
| Ogikubo Hospital | Suginami | Tokyo | 167-0035 | Japan |
| Hiroshima University Hospital | Hiroshima | 734-8551 | Japan |
| Haematology Service, Canterbury Health Laboratories | Christchurch | 8011 | New Zealand |
| Eulji University Hospital | Daejeon | 35233 | South Korea |
| Changhua Christian Hospital | Changhua | 50006 | Taiwan |
| University Hospital of Wales | Cardiff | CF14 4XW | United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| FG002 | BAY1093884 400mg | Subjects received BAY1093884 400mg once a week until premature termination of the study |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set (SAF): all subjects with at least one intake of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | BAY1093884 100mg | Subjects received BAY1093884 100 mg once a week until premature termination of the study |
| BG001 | BAY1093884 225mg | Subjects received BAY1093884 225 mg once a week until premature termination of the study |
| BG002 | BAY1093884 400mg | Subjects received BAY1093884 400mg once a week until premature termination of the study |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety analysis set (SAF): all participants with at least one intake of study drug | Posted | Count of Participants | Participants | 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 |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | 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. | Safety analysis set (SAF): all participants with at least one intake of study drug | Posted | Count of Participants | Participants | 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 |
| ||||||||||||||||||||||||||||||||||
| Primary | 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. | Safety analysis set (SAF): all participants with at least one intake of study drug | Posted | Count of Participants | Participants | 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 |
| ||||||||||||||||||||||||||||||||||
| Primary | 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. | Safety analysis set (SAF): all participants with at least one intake of study drug | Posted | Count of Participants | Participants | 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 |
|
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BAY1093884 100mg | Subjects received BAY1093884 100 mg once a week until premature termination of the study | 0 | 8 | 1 | 8 | 7 | 8 |
| EG001 | BAY1093884 225mg | Subjects received BAY1093884 225 mg once a week until premature termination of the study | 0 | 8 | 2 | 8 | 6 | 8 |
| EG002 | BAY1093884 400mg | Subjects received BAY1093884 400 mg once a week until premature termination of the study | 0 | 8 | 1 | 8 | 6 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal artery thrombosis | Eye disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Paranasal sinus neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Non-systematic Assessment |
| |
| Transverse sinus thrombosis | Nervous system disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (22.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypofibrinogenaemia | Blood and lymphatic system disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Tooth development disorder | Gastrointestinal disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Perianal erythema | Gastrointestinal disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Anal pruritus | Gastrointestinal disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Injection site inflammation | General disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Application site inflammation | General disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (22.1) | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (22.1) | Non-systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA (22.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (22.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (22.1) | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (22.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (22.1) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (22.1) | Non-systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | MedDRA (22.1) | Non-systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MedDRA (22.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Non-systematic Assessment |
| |
| Paranasal sinus neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Pharyngeal hypoaesthesia | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA (22.1) | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (22.1) | Non-systematic Assessment |
|
Acceptable safety and tolerability of befovacimab was not demonstrated in the study, prompting early termination of the study. The "post-hoc" SAP was used for analyses. The other SAP was pre-specified but became not applicable after the termination.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | 1-888-8422937 | clinical-trials-contact@bayer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 10, 2020 | Oct 13, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| C051928 | lipoprotein-associated coagulation inhibitor |
| D000911 | Antibodies, Monoclonal |
| D007074 | Immunoglobulin G |
| ID | Term |
|---|---|
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007132 | Immunoglobulin Isotypes |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Subjects received BAY1093884 400mg once a week until premature termination of the study
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|