A Phase 3 Clinical Study of KW-3357 in Patients With DIC
- Registration Number
- NCT01384409
- 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 Japanese Association for Acute Medicine-defined DIC criteria.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description KW-3357 KW-3357 -
- Primary Outcome Measures
Name Time Method DIC score Screening, 2, 3, 4, 5, 6 days (or discontinuation) Based on the Japanese Association for Acute Medicine-defined DIC criteria
Mortality 28 days Safety up to 6 days (or discontinuation) Number of patients with adverse events
Organ symptoms Screening, 4, 6 days (or discontinuation) Sepsis related organ failure assessment score
Severity Screening, 4, 6 days (or discontinuation) The Acute Physiology and Chronic Health Evaluation II score
Plasma antithrombin activity Screening, 2, 3, 4, 5, 6 days (or discontinuation) DIC resolution 6 days (or discontinuation) Japanese Association for Acute Medicine-defined DIC criteria score \< 4
- Secondary Outcome Measures
Name Time Method