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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020373-17 | EudraCT Number | ||
| 271101 | Other Identifier | Baxter Healthcare Corporation |
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The purpose of this study is to examine the safety, tolerability and the way the body handles various single and multiple doses of ARC19499 in patients with hemophilia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| saline for injection | Placebo Comparator |
| |
| ARC19499 Low Dose | Experimental |
| |
| ARC19499 Mid Dose | Experimental |
| |
| ARC19499 High Dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo control | Drug | sterile saline for injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of ARC19499 | The PK profile of ARC19499 administered by single and multiple subcutaneous injections will be characterized. The bioavailability of subcutaneously injected ARC19499 relative to that of intravenously infused ARC19499 will be determined. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Coagulation system pharmacodynamic (PD) effects of ARC19499. | The PD profile of ARC19499 with respect to the kinetics of thrombin generation and clot formation will be characterized. | 2 weeks |
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Inclusion Criteria:
Adult male patients ≥18 to ≤75 years of age.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London | United Kingdom |
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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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| ID | Term |
|---|---|
| C577143 | ARC19499 |
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| ARC19499 |
| Drug |
Anti-tissue factor pathway inhibitor (TFPI) aptamer |
|
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |