An Open-label Study of KW-3357

An Open-label Study of KW-3357 Compared to Plasma-derived Antithrombin for Disseminated Intravascular Coagulation (DIC) Associated With Infection

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.

Inclusion Criteria:

• Meet the ACCP/SCCM-defined sepsis criteria
• Japanese Association for Acute Medicine-defined DIC criteria score >= 4
• Antithrombin activity <= 70%
• Written informed consent from patient or guardian

Exclusion Criteria:

• Anamnesis or complication of serious drug allergy
• Serious liver disorder, such as fulminant hepatitis and decompensated cirrhosis
• Pregnant, nursing, or possibly pregnant woman