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

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ClinicalTrials.gov Identifier: NCT03597022
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
The purpose of this study is 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 is 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: BAY1093884 Phase 2

Detailed Description:
The primary objective of the study is 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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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : November 5, 2019
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Arm Intervention/treatment
Experimental: Hemophilia patients_Arm 1
Patients receive a dose of 100 mg of BAY1093884.
Drug: BAY1093884
Patients will receive a subcutaneous injection of BAY1093884 once per week.
Other Name: Anti-TFPI (Tissue Factor Pathway Inhibitor) monoclonal antibody (immunoglobulin G2; IgG2)

Experimental: Hemophilia patients_Arm 2
Patients receive a dose of >100 mg and <400 mg of BAY1093884.
Drug: BAY1093884
Patients will receive a subcutaneous injection of BAY1093884 once per week.
Other Name: Anti-TFPI (Tissue Factor Pathway Inhibitor) monoclonal antibody (immunoglobulin G2; IgG2)

Experimental: Hemophilia patients_Arm 3
Patients receive a dose of BAY1093884 that is between the dose of Arm 2 and 400 mg.
Drug: BAY1093884
Patients will receive a subcutaneous injection of BAY1093884 once per week.
Other Name: Anti-TFPI (Tissue Factor Pathway Inhibitor) monoclonal antibody (immunoglobulin G2; IgG2)




Primary Outcome Measures :
  1. Frequency of drug-related adverse events (AEs) [ Time Frame: Up to 22 months ]
  2. Frequency of drug-related serious adverse events (SAEs) [ Time Frame: Up to 22 months ]
  3. Frequency of adverse events of special interest (AESIs) [ Time Frame: Up to 22 months ]
    Includes thromboembolic and thrombotic microangiopathic events and hypersensitivity reactions.

  4. Frequency of clinically relevant abnormalities in laboratory values [ Time Frame: Up to 22 months ]
    Includes various hematological and serum chemical parameters.



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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/mm3

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


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

  Show 37 Study Locations
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03597022     History of Changes
Other Study ID Numbers: 19580
2017-003324-67 ( EudraCT Number )
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

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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:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Immunoglobulins
Immunoglobulin G
Factor VIII
Lipoprotein-associated coagulation inhibitor
Immunologic Factors
Physiological Effects of Drugs
Coagulants
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Factor Xa Inhibitors
Antithrombins