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To investigate the impact of impaired renal function on the pharmacokinetics of ART-123 in patients with Disseminated Intravascular Coagulation.
To investigate the safety of ART-123 in patients with Disseminated Intravascular Coagulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal impairment grade 0 | Experimental |
| |
| Renal impairment grade 1 | Experimental |
| |
| Renal impairment grade 2 | Experimental |
| |
| Renal impairment grade 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ART-123 | Drug | 380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Pharmacokinetics | Cmax, Area Under Curve, T1/2,CLtot,CLR | pre-dose, 0,2,4,8,24 hours post-dose |
| Incidence rate of hemorrhage related adverse events | from the start of infusion to 8days after the cessation of infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ōita | Japan |
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| ID | Term |
|---|---|
| D004211 | Disseminated Intravascular Coagulation |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| C472045 | ART123 |
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|
| D019851 | Thrombophilia |