A Clinical Study of KW-3357 in Patients With DIC
- Registration Number
- NCT01384396
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description KW-3357 KW-3357 -
- Primary Outcome Measures
Name Time Method Safety up to 6 days (or discontinuation) Number of patients with adverse events
DIC resolution 6 days (or discontinuation) Resolution from DIC by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare
- Secondary Outcome Measures
Name Time Method DIC score 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
Plasma antithrombin activity Screening, 2, 3, 4, 5, 6 days (or discontinuation) Mortality 28 days