A Phase 3 Clinical Study of KW-3357 in Patients With DIC

A Clinical Study of KW-3357 in Patients Diagnosed as Disseminated Intravascular Coagulation (DIC) by Japanese Association for Acute Medicine-defined DIC Criteria

To evaluate the efficacy and safety of KW-3357 with concomitant use of heparin using multi-center, non-comparative, open-label method in patients diagnosed as disseminated intravascular coagulation (DIC) by Japanese Association for Acute Medicine-defined DIC criteria.

Inclusion 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
• Possibility for the promotion of bleeding by concomitant use of heparin