check_circleStudy Completed

Hemophilia A; Hemophilia B

Bayer Identifier:

19592

ClinicalTrials.gov Identifier:

NCT03481946

EudraCT Number:

Not Available

EU CT Number:

Not Available
A study to assess pharmacokinetics and pharmacodynamics following administration of BAY1093884 in patients with severe hemophilia

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

18 - 65 Years
  • - 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
  • - 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.

Trial summary

Enrollment Goal
6
Trial Dates
May 2018 - February 2019
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY1093884
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Chaim Sheba Medical CenterRamat Gan, 5262000, Israel

Primary Outcome

  • AUC (0-tlast) of BAY1093884 in plasma
    Area under the concentration vs. time curve from time 0 to the last data point > LLOQ
    date_rangeTime Frame:
    Up to 15 days after drug administration
  • AUC(0-tlast)/D of BAY1093884 in plasma
    AUC(0-tlast) divided by dose
    date_rangeTime Frame:
    Up to 15 days after drug administration
  • Cmax of BAY1093884 in plasma
    Maximum observed drug concentration in measured matrix after single dose administration
    date_rangeTime Frame:
    Up to 15 days after drug administration
  • Cmax/D of BAY1093884 in plasma
    Cmax divided by dose
    date_rangeTime Frame:
    Up to 15 days after drug administration

Secondary Outcome

  • Tissue factor plasma inhibitor activity: effect of BAY1093884 to inhibit the anticoagulatory activity of plasma TFPI as assessed by a chromogenic assay
    date_rangeTime Frame:
    Up to 15 days after drug administration

Trial design

A Phase 1 Study to assess pharmacokinetics and pharmacodynamics following administration of BAY1093884 in patients with severe hemophilia
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1