Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
221 participants
INTERVENTIONAL
2011-06-30
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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KW-3357
KW-3357
Intravenous infusion once a day
Plasma-derived antithrombin
Plasma-derived antithrombin
Intravenous infusion once a day
Interventions
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KW-3357
Intravenous infusion once a day
Plasma-derived antithrombin
Intravenous infusion once a day
Eligibility Criteria
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Inclusion Criteria
* Japanese Association for Acute Medicine-defined DIC criteria score \>= 4
* Antithrombin activity \<= 70%
* Written informed consent from patient or guardian
Exclusion Criteria
* Serious liver disorder, such as fulminant hepatitis and decompensated cirrhosis
* Pregnant, nursing, or possibly pregnant woman
20 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Saga, , Japan
Countries
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References
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Endo S, Shimazaki R; Antithrombin Gamma Study Group. An open-label, randomized, phase 3 study of the efficacy and safety of antithrombin gamma in patients with sepsis-induced disseminated intravascular coagulation syndrome. J Intensive Care. 2018 Nov 16;6:75. doi: 10.1186/s40560-018-0339-z. eCollection 2018.
Other Identifiers
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3357-004
Identifier Type: -
Identifier Source: org_study_id
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