Clinical Trial: A Phase 3 Clinical Study of KW-3357 in Patients With DIC
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Clinical Study of KW-3357 in Patients Diagnosed as Disseminated Intravascular Coagulation (DIC) by Japanese Association for Acute Medicine-defined DIC Criteria
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 Japanese Association for Acute Medicine-defined DIC criteria.
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) ]Japanese Association for Acute Medicine-defined DIC criteria score < 4
- DIC score [ Time Frame: Screening, 2, 3, 4, 5, 6 days (or discontinuation) ]Based on the Japanese Association for Acute Medicine-defined DIC criteria
- Mortality [ Time Frame: 28 days ]
- Organ symptoms [ Time Frame: Screening, 4, 6 days (or discontinuation) ]Sepsis related organ failure assessment score
- Severity [ Time Frame: Screening, 4, 6 days (or discontinuation) ]The Acute Physiology and Chronic Health Evaluation II score
- Plasma antithrombin activity [ Time Frame: Screening, 2, 3, 4, 5, 6 days (or discontinuation) ]
Original Primary Outcome:
- SafetyNumber of patients with adverse events
- DIC resolutionJapanese Association for Acute Medicine-defined DIC criteria score < 4
- DIC scoreBased on the Japanese Association for Acute Medicine-defined DIC criteria
- Mortality
- Organ symptomsSepsis related organ failure assessment score
- SeverityThe Acute Physiology and Chronic Health Evaluation II score
- Plasma antithrombin activity
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Kyowa Hakko Kirin Co., Ltd
Dates:
Date Received: June 27, 2011
Date Started: February 2012
Date Completion:
Last Updated: March 22, 2017
Last Verified: March 2017