An Open-label Study of KW-3357
Phase 3
Completed
- Conditions
- Disseminated Intravascular Coagulation (DIC)
- Interventions
- Drug: Plasma-derived antithrombin
- Registration Number
- NCT01384903
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of KW-3357 compared to plasma-derived antithrombin using multi-center, open-label, parallel-group, comparative method in patients with Disseminated Intravascular Coagulation (DIC) associated with infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 221
Inclusion Criteria
- Meet the ACCP/SCCM-defined sepsis 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KW-3357 KW-3357 - Plasma-derived antithrombin Plasma-derived antithrombin -
- Primary Outcome Measures
Name Time Method DIC resolution 6 days (or discontinuation) Japanese Association for Acute Medicine-defined DIC criteria score \< 4
- Secondary Outcome Measures
Name Time Method Mortality 28 days Plasma antithrombin activity Screening, 2, 3, 4, 5, 6 days (or discontinuation) DIC score Screening, 2, 3, 4, 5, 6 days (or discontinuation) Based on the Japanese Association for Acute Medicine-defined DIC criteria score
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
Number of patients with adverse events up to 6 days (or discontinuation)