NCT01384396|CompletedPhase 3
A Clinical Study of KW-3357 in Patients With DIC
3357-005
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3357-005
Sponsor study identifier
interventional
15
1 country
1
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2013
Actual (reported)Study Completion
April 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 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 27, 2011
Actual (reported)June 29, 2011
Actual (reported)December 2011
Date type not reportedThis date has not been verified as actual or estimated.
April 2013
Actual (reported)April 2013
Actual (reported)Safety
Number of patients with adverse events
up to 6 days (or discontinuation)
DIC resolution
Resolution from DIC by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare
6 days (or discontinuation)
DIC score
Screening, 2, 3, 4, 5, 6 days (or discontinuation)
Mortality
28 days
Plasma antithrombin activity
Screening, 2, 3, 4, 5, 6 days (or discontinuation)
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.
Kanazawa, Japan
15 participants (actual enrollment reported by the registry).
First Submitted
June 27, 2011
First Posted
June 29, 2011
Study Start
December 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
April 2013
Actual (reported)Study Completion
April 2013
Actual (reported)Last Updated
March 24, 2017
Record last verified: 2017-03
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Source: ClinicalTrials.gov.
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