A Clinical Study of KW-3357 in Patients With DIC

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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 the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.

Criteria

Inclusion Criteria:

• Diagnosed or suspected as DIC by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare

• 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