3357-006
A Clinical Study of KW-3357 in Patients Diagnosed as Disseminated Intravascular Coagulation (DIC) by Japanese Association for Acute Medicine-defined DIC Criteria
Sponsor study identifier
interventional
5
1 country
1
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
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 Japanese Association for Acute Medicine-defined DIC criteria.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2012
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)February 2012
Date type not reportedThis date has not been verified as actual or estimated.
October 2012
Actual (reported)October 2012
Actual (reported)Safety
Number of patients with adverse events
up to 6 days (or discontinuation)
DIC resolution
Japanese Association for Acute Medicine-defined DIC criteria score \< 4
6 days (or discontinuation)
DIC score
Based on the Japanese Association for Acute Medicine-defined DIC criteria
Screening, 2, 3, 4, 5, 6 days (or discontinuation)
Mortality
28 days
Organ symptoms
Sepsis related organ failure assessment score
Screening, 4, 6 days (or discontinuation)
Severity
The Acute Physiology and Chronic Health Evaluation II score
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
5 participants (actual enrollment reported by the registry).
First Submitted
June 27, 2011
First Posted
June 29, 2011
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
International Prospective Registry of Disseminated Intravascular Coagulation
Screening, 4, 6 days (or discontinuation)
Plasma antithrombin activity
Screening, 2, 3, 4, 5, 6 days (or discontinuation)
Contact the study team to confirm eligibility.
Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)Last Updated
March 24, 2017
Record last verified: 2017-03
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Source: ClinicalTrials.gov.
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