Back to resultsA Phase 3 Clinical Study of KW-3357 in Patients With DIC (3357-006)
Primary Purpose
Disseminated Intravascular Coagulation (DIC)
Status
Terminated
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KW-3357
Sponsored by
About this trial
This is an interventional treatment trial for Disseminated Intravascular Coagulation (DIC)
Eligibility Criteria
Inclusion Criteria:
- Japanese Association for Acute Medicine-defined DIC criteria score >= 4
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KW-3357
Arm Description
Outcomes
Primary Outcome Measures
Safety
Number of patients with adverse events
DIC resolution
Japanese Association for Acute Medicine-defined DIC criteria score < 4
DIC score
Based on the Japanese Association for Acute Medicine-defined DIC criteria
Mortality
Organ symptoms
Sepsis related organ failure assessment score
Severity
The Acute Physiology and Chronic Health Evaluation II score
Plasma antithrombin activity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01384409
Brief Title
A Phase 3 Clinical Study of KW-3357 in Patients With DIC
Acronym
3357-006
Official Title
A Clinical Study of KW-3357 in Patients Diagnosed as Disseminated Intravascular Coagulation (DIC) by Japanese Association for Acute Medicine-defined DIC Criteria
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disseminated Intravascular Coagulation (DIC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KW-3357
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KW-3357
Intervention Description
Intravenous infusion once a day
Primary Outcome Measure Information:
Title
Safety
Description
Number of patients with adverse events
Time Frame
up to 6 days (or discontinuation)
Title
DIC resolution
Description
Japanese Association for Acute Medicine-defined DIC criteria score < 4
Time Frame
6 days (or discontinuation)
Title
DIC score
Description
Based on the Japanese Association for Acute Medicine-defined DIC criteria
Time Frame
Screening, 2, 3, 4, 5, 6 days (or discontinuation)
Title
Mortality
Time Frame
28 days
Title
Organ symptoms
Description
Sepsis related organ failure assessment score
Time Frame
Screening, 4, 6 days (or discontinuation)
Title
Severity
Description
The Acute Physiology and Chronic Health Evaluation II score
Time Frame
Screening, 4, 6 days (or discontinuation)
Title
Plasma antithrombin activity
Time Frame
Screening, 2, 3, 4, 5, 6 days (or discontinuation)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Japanese Association for Acute Medicine-defined DIC criteria score >= 4
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
Facility Information:
City
Saga
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Phase 3 Clinical Study of KW-3357 in Patients With DIC
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