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

Phase 1

Completed

• Conditions: Hemophilia A; Hemophilia B
• Interventions: Drug: BAY1093884

• Registration Number: NCT03481946
• Lead Sponsor: 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-03-29
• Study Start: 2018-05-10
• Primary Completion: 2018-10-17
• Study Completion: 2019-02-20
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-15
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BAY1093884 in subjects with Hemophilia	BAY1093884	Single dose of BAY1093884 over 30 minutes administered in subjects with severe congenital Hemophilia A or B, with inhibitors or without inhibitors

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chaim Sheba Medical Center; 🇮🇱 Ramat Gan, Israel