Overview
A Phase 3 Clinical Study of KW-3357 in Patients With DIC
Status:
Terminated
Terminated
Trial end date:
2012-10-01
2012-10-01
Target enrollment:
0
0
Participant gender:
All
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 Japanese Association for Acute Medicine-defined DIC criteria.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Kyowa Hakko Kirin Company, Limited
Kyowa Kirin Co., Ltd.
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