Clinical Trial: A Clinical Study of KW-3357 in Patients With DIC
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Clinical Study of KW-3357 in Patients Diagnosed as Disseminated Intravascular Coagulation (DIC) by the Diagnostic Criteria for DIC Established by the Japanese Ministry o
Brief 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.
Detailed Summary:
Sponsor: Kyowa Hakko Kirin Co., Ltd
Current Primary Outcome:
- Safety [ Time Frame: up to 6 days (or discontinuation) ]Number of patients with adverse events
- DIC resolution [ Time Frame: 6 days (or discontinuation) ]Resolution from DIC by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare
Original Primary Outcome:
- SafetyNumber of patients with adverse events
- DIC resolutionResolution from DIC by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare
Current Secondary Outcome:
- DIC score [ Time Frame: Screening, 2, 3, 4, 5, 6 days (or discontinuation) ]Based on the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare
- Mortality [ Time Frame: 28 days ]
- Plasma antithrombin activity [ Time Frame: Screening, 2, 3, 4, 5, 6 days (or discontinuation) ]
Original Secondary Outcome:
- DIC scoreBased on the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare
- Mortality
- Plasma antithrombin activity
Information By: Kyowa Hakko Kirin Co., Ltd
Dates:
Date Received: June 27, 2011
Date Started: December 2011
Date Completion:
Last Updated: March 22, 2017
Last Verified: March 2017