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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY1093884 in subjects with Hemophilia | Experimental | Single dose of BAY1093884 over 30 minutes administered in subjects with severe congenital Hemophilia A or B, with inhibitors or without inhibitors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1093884 | Drug | 0.3 mg/kg given intravenously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC (0-tlast) of BAY1093884 in plasma | Area under the concentration vs. time curve from time 0 to the last data point > LLOQ | Up to 15 days after drug administration |
| AUC(0-tlast)/D of BAY1093884 in plasma | AUC(0-tlast) divided by dose | Up to 15 days after drug administration |
| Cmax of BAY1093884 in plasma | Maximum observed drug concentration in measured matrix after single dose administration | Up to 15 days after drug administration |
| Cmax/D of BAY1093884 in plasma | Cmax divided by dose | Up to 15 days after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chaim Sheba Medical Center | Ramat Gan | 5262000 | Israel |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| BAY1093884 |
| Drug |
1 mg/kg given intravenously |
|
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |