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A Study to Assess Pharmacokinetics and Pharmacodynamics Following Administration of BAY1093884 in Patients With Severe Hemophilia

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ClinicalTrials.gov Identifier: NCT03481946
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

The primary objective of this study is to assess the pharmacokinetics in patients with severe hemophilia.

The secondary objective is to assess the pharmacodynamics of BAY1093884 based on tissue factor pathway inhibitor activity


Condition or disease Intervention/treatment Phase
Hemophilia A; Hemophilia B Drug: BAY1093884 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1 Study to Assess Pharmacokinetics and Pharmacodynamics Following Administration of BAY1093884 in Patients With Severe Hemophilia
Actual Study Start Date : May 10, 2018
Actual Primary Completion Date : October 17, 2018
Actual Study Completion Date : February 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Arm Intervention/treatment
Experimental: BAY1093884 in subjects with Hemophilia
Single dose of BAY1093884 over 30 minutes administered in subjects with severe congenital Hemophilia A or B, with inhibitors or without inhibitors
Drug: BAY1093884
0.3 mg/kg given intravenously

Drug: BAY1093884
1 mg/kg given intravenously




Primary Outcome Measures :
  1. AUC (0-tlast) of BAY1093884 in plasma [ Time Frame: Up to 15 days after drug administration ]
    Area under the concentration vs. time curve from time 0 to the last data point > LLOQ

  2. AUC(0-tlast)/D of BAY1093884 in plasma [ Time Frame: Up to 15 days after drug administration ]
    AUC(0-tlast) divided by dose

  3. Cmax of BAY1093884 in plasma [ Time Frame: Up to 15 days after drug administration ]
    Maximum observed drug concentration in measured matrix after single dose administration

  4. Cmax/D of BAY1093884 in plasma [ Time Frame: Up to 15 days after drug administration ]
    Cmax divided by dose


Secondary Outcome Measures :
  1. Tissue factor plasma inhibitor activity: effect of BAY1093884 to inhibit the anticoagulatory activity of plasma TFPI as assessed by a chromogenic assay [ Time Frame: Up to 15 days after drug administration ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males with severe congenital hemophilia A or B defined as <1% FVIII or <2% FIX concentration by measurement at the time of screening or from reliable prior documentation (e.g., measurement in other clinical Bayer trials, or diagnostic genetic testing)
  • Male with any inhibitor titer at screening or prior to screening at any time from medical records. Subjects may be receiving a bypassing agent (rFVIIa; NovoSeven and/or aPCC; FEIBA) for treatment.
  • Age: 18 to 65 years at screening
  • BMI: 18 to 29.9 kg/m2

Exclusion Criteria:

  • Subjects with known bleeding disorders (such as von Willebrand factor [vWF] deficiency, FXI deficiency, platelet disorders, or known acquired or inherited thrombophilia etc.) other than congenital Hemophilia A or B with or without inhibitors
  • History of angina pectoris or treatment for angina pectoris
  • History of coronary and/or peripheral atherosclerotic disease, congestive heart failure, disseminated intravascular coagulopathy, or stage 2 hypertension defined as systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg even if controlled
  • History of thrombophlebitis, venous/arterial thromboembolic diseases (particularly deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, cerebrovascular accident, ischemic heart disease, transient ischemic attack)
  • Known or suspected hypersensitivity of the immune system, history of anaphylactic reaction, known severe allergies, non-allergic drug reactions, or multiple drug allergies
  • Subjects with inhibitors treated with FEIBA, who are not willing to accept rFVIIa (NovoSeven) for the treatment of any bleeds occurring either between screening and dosing or after study drug administration, and until the end of the study.

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): NCT03481946


Locations
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Israel
Chaim Sheba Medical Center
Ramat Gan, Israel, 5262000
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03481946     History of Changes
Other Study ID Numbers: 19592
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 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
Additional relevant MeSH terms:
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Hemophilia A
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked