Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multiple Escalating Dose Study of BAY1093884 in Adults With Hemophilia A or B With or Without Inhibitors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03597022
Recruitment Status : Terminated (Due to thrombosis)
First Posted : July 24, 2018
Results First Posted : November 30, 2020
Last Update Posted : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hemophilia A and B Drug: Befovacimab (BAY1093884) Phase 2

Detailed Description:
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.

Layout table for study information
Study Type : Interventional
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multiple Escalating Dose Study of BAY1093884 in Adults With Hemophilia A or B With or Without Inhibitors
Actual Study Start Date : July 24, 2018
Actual Primary Completion Date : October 15, 2019
Actual Study Completion Date : October 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Arm Intervention/treatment
Experimental: BAY1093884 100mg
Subjects received BAY1093884 100 mg once a week until premature termination of the study
Drug: Befovacimab (BAY1093884)
Once weekly doses until premature termination of the study, subcutaneous injection
Other Name: Anti-TFPI (Tissue Factor Pathway Inhibitor) monoclonal antibody (immunoglobulin G2; IgG2)

Experimental: BAY1093884 225mg
Subjects received BAY1093884 225 mg once a week until premature termination of the study
Drug: Befovacimab (BAY1093884)
Once weekly doses until premature termination of the study, subcutaneous injection
Other Name: Anti-TFPI (Tissue Factor Pathway Inhibitor) monoclonal antibody (immunoglobulin G2; IgG2)

Experimental: BAY1093884 400mg
Subjects received BAY1093884 400mg once a week until premature termination of the study
Drug: Befovacimab (BAY1093884)
Once weekly doses until premature termination of the study, subcutaneous injection
Other Name: Anti-TFPI (Tissue Factor Pathway Inhibitor) monoclonal antibody (immunoglobulin G2; IgG2)




Primary Outcome Measures :
  1. Number of Participants With Drug-related Treatment-emergent Adverse Events [ Time 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 ]
    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.

  2. Number of Participants With Serious Treatment-emergent Adverse Events [ Time 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 ]
    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.

  3. Number of Participants With Treatment-emergent Adverse Events of Special Interest [ Time 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 ]
    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.

  4. Number of Participants With Clinically Relevant Abnormalities in Laboratory Values [ Time 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 ]
    "Clinically relevant "implied the presence of a clinical sign or symptom that required medical action.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03597022


Locations
Show Show 17 study locations
Sponsors and Collaborators
Bayer
  Study Documents (Full-Text)

Documents provided by Bayer:
Study Protocol  [PDF] April 5, 2019
Statistical Analysis Plan  [PDF] March 10, 2020

Additional Information:
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03597022    
Other Study ID Numbers: 19580
2017-003324-67 ( EudraCT Number )
First Posted: July 24, 2018    Key Record Dates
Results First Posted: November 30, 2020
Last Update Posted: November 30, 2020
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Bayer:
Subcutaneous
Prophylaxis
Non-Inhibitors
Inhibitors
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Lipoprotein-associated coagulation inhibitor
Immunoglobulins
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Factor Xa Inhibitors
Antithrombins