NCT01384903|CompletedPhase 3
An Open-label Study of KW-3357
3357-004
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3357-004
Sponsor study identifier
interventional
221
1 country
1
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2013
Actual (reported)Study Completion
May 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
June 27, 2011
Actual (reported)June 29, 2011
Actual (reported)May 2013
Actual (reported)May 2013
Actual (reported)DIC resolution
Japanese Association for Acute Medicine-defined DIC criteria score \< 4
6 days (or discontinuation)
DIC score
Screening, 2, 3, 4, 5, 6 days (or discontinuation)
Mortality
28 days
Organ symptoms
Screening, 4, 6 days (or discontinuation)
Severity
Screening, 4, 6 days (or discontinuation)
Plasma antithrombin activity
Screening, 2, 3, 4, 5, 6 days (or discontinuation)
Intravenous infusion once a day
Intravenous infusion once a day
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Saga, Japan
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.
221 participants (actual enrollment reported by the registry).
First Submitted
June 27, 2011
First Posted
June 29, 2011
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
International Prospective Registry of Disseminated Intravascular Coagulation
Contact the study team to confirm eligibility.
Primary Completion
May 2013
Actual (reported)Study Completion
May 2013
Actual (reported)Last Updated
March 24, 2017
Record last verified: 2017-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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