Back to resultsAn Open-label Study of KW-3357 (3357-004)
Primary Purpose
Disseminated Intravascular Coagulation (DIC)
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KW-3357
Plasma-derived antithrombin
Sponsored by
About this trial
This is an interventional treatment trial for Disseminated Intravascular Coagulation (DIC)
Eligibility Criteria
Inclusion Criteria:
- Meet the ACCP/SCCM-defined sepsis 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
KW-3357
Plasma-derived antithrombin
Arm Description
Outcomes
Primary Outcome Measures
DIC resolution
Japanese Association for Acute Medicine-defined DIC criteria score < 4
Secondary Outcome Measures
DIC score
Based on the Japanese Association for Acute Medicine-defined DIC criteria score
Mortality
Organ symptoms
Sepsis related organ failure assessment score
Severity
The Acute Physiology and Chronic Health Evaluation II score
Plasma antithrombin activity
Number of patients with adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01384903
Brief Title
An Open-label Study of KW-3357
Acronym
3357-004
Official Title
An Open-label Study of KW-3357 Compared to Plasma-derived Antithrombin for Disseminated Intravascular Coagulation (DIC) Associated With Infection
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (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
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.
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
221 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KW-3357
Arm Type
Experimental
Arm Title
Plasma-derived antithrombin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
KW-3357
Intervention Description
Intravenous infusion once a day
Intervention Type
Drug
Intervention Name(s)
Plasma-derived antithrombin
Intervention Description
Intravenous infusion once a day
Primary Outcome Measure Information:
Title
DIC resolution
Description
Japanese Association for Acute Medicine-defined DIC criteria score < 4
Time Frame
6 days (or discontinuation)
Secondary Outcome Measure Information:
Title
DIC score
Description
Based on the Japanese Association for Acute Medicine-defined DIC criteria score
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)
Title
Number of patients with adverse events
Time Frame
up to 6 days (or discontinuation)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet the ACCP/SCCM-defined sepsis 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
Facility Information:
City
Saga
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
30473794
Citation
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.
Results Reference
derived
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An Open-label Study of KW-3357
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