- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01384396
A Clinical Study of KW-3357 in Patients With DIC (3357-005)
March 22, 2017 updated by: Kyowa Kirin Co., Ltd.
A Clinical Study of KW-3357 in Patients Diagnosed as Disseminated Intravascular Coagulation (DIC) by the Diagnostic Criteria for DIC Established by the Japanese Ministry of Health and Welfare
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Kanazawa, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosed or suspected as DIC by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare
- 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
- Possibility for the promotion of bleeding by concomitant use of heparin
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: KW-3357
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Intravenous infusion once a day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: up to 6 days (or discontinuation)
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Number of patients with adverse events
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up to 6 days (or discontinuation)
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DIC resolution
Time Frame: 6 days (or discontinuation)
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Resolution from DIC by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare
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6 days (or discontinuation)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 28 days
|
28 days
|
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Plasma antithrombin activity
Time Frame: Screening, 2, 3, 4, 5, 6 days (or discontinuation)
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Screening, 2, 3, 4, 5, 6 days (or discontinuation)
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DIC score
Time Frame: Screening, 2, 3, 4, 5, 6 days (or discontinuation)
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Based on the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare
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Screening, 2, 3, 4, 5, 6 days (or discontinuation)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
June 27, 2011
First Submitted That Met QC Criteria
June 28, 2011
First Posted (Estimate)
June 29, 2011
Study Record Updates
Last Update Posted (Actual)
March 24, 2017
Last Update Submitted That Met QC Criteria
March 22, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3357-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Disseminated Intravascular Coagulation (DIC)
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Kyowa Kirin Co., Ltd.TerminatedDisseminated Intravascular Coagulation (DIC)Japan
-
Kyowa Kirin Co., Ltd.Completed
-
Qilu Hospital of Shandong UniversityRecruitingDisseminated Intravascular CoagulationChina
-
Asahi Kasei Pharma CorporationCompletedDisseminated Intravascular CoagulationJapan
-
Marcella MullerUniversità degli Studi dell'Insubria; Juntendo University; University of Chieti; Ospedale S. Antonio and other collaboratorsUnknownDisseminated Intravascular CoagulationNetherlands
-
University of MiamiCompletedCoagulation; IntravascularUnited States
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The University of Texas Health Science Center,...TerminatedSepsis | Disseminated Intravascular CoagulationUnited States
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LEO PharmaTerminatedDisseminated Intravascular Coagulation
-
Hallym University Medical CenterUnknown
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China Medical University, ChinaThe First Affiliated Hospital of Nanchang University; Peking University People... and other collaboratorsRecruitingSepsis | Disseminated Intravascular CoagulationChina
Clinical Trials on KW-3357
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Kyowa Kirin Co., Ltd.TerminatedDisseminated Intravascular Coagulation (DIC)Japan
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Kyowa Hakko Kirin UK, Ltd.CompletedCongenital Antithrombin DeficiencyFrance, Germany, Italy, Sweden, United Kingdom
-
Kyowa Kirin Co., Ltd.Completed
-
Kyowa Kirin Co., Ltd.Completed
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Kyowa Kirin, Inc.CompletedHepatic ImpairmentUnited States
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Kyowa Kirin, Inc.CompletedHealthy Male SubjectsUnited States
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Kyowa Hakko Kirin Pharma, Inc.TerminatedAcute Myelogenous Leukemia (AML)United States
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Kyowa Hakko Kirin Pharma, Inc.Completed
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Kyowa Hakko Kirin UK, Ltd.CompletedMultiple Myeloma | Chronic Lymphocytic Leukaemia | B-cell Non-Hodgkin's LymphomaUnited Kingdom
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Kyowa Kirin, Inc.TerminatedMyelodysplastic Syndromes | Acute Lymphoblastic Leukemia | Acute Myelogenous Leukemia | Chronic Myelogenous LeukemiaUnited States