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The purpose of this study is to evaluate the efficacy and safety of KW-3357 compared to plasma-derived antithrombin using multi-center, open-label, parallel-group, comparative method in patients with Disseminated Intravascular Coagulation (DIC) associated with infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KW-3357 | Experimental |
| |
| Plasma-derived antithrombin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KW-3357 | Drug | Intravenous infusion once a day |
| |
| Plasma-derived antithrombin |
| Measure | Description | Time Frame |
|---|---|---|
| DIC resolution | Japanese Association for Acute Medicine-defined DIC criteria score < 4 | 6 days (or discontinuation) |
| Measure | Description | Time Frame |
|---|---|---|
| DIC score | Based on the Japanese Association for Acute Medicine-defined DIC criteria score | Screening, 2, 3, 4, 5, 6 days (or discontinuation) |
| Mortality | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saga | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30473794 | Derived | Endo S, Shimazaki R; Antithrombin Gamma Study Group. An open-label, randomized, phase 3 study of the efficacy and safety of antithrombin gamma in patients with sepsis-induced disseminated intravascular coagulation syndrome. J Intensive Care. 2018 Nov 16;6:75. doi: 10.1186/s40560-018-0339-z. eCollection 2018. |
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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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| Drug |
Intravenous infusion once a day |
|
| Organ symptoms | Sepsis related organ failure assessment score | Screening, 4, 6 days (or discontinuation) |
| Severity | The Acute Physiology and Chronic Health Evaluation II score | Screening, 4, 6 days (or discontinuation) |
| Plasma antithrombin activity | Screening, 2, 3, 4, 5, 6 days (or discontinuation) |
| Number of patients with adverse events | up to 6 days (or discontinuation) |
| D019851 | Thrombophilia |