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:

• Safety
  Number of patients with adverse events
• DIC resolution
  Resolution 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 score
  Based 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