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A Clinical Study of KW-3357 in Patients With DIC (3357-005)

Primary Purpose

Disseminated Intravascular Coagulation (DIC)

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KW-3357
Sponsored by
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disseminated Intravascular Coagulation (DIC)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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
Resolution from DIC by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare

Secondary Outcome Measures

DIC score
Based on the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare
Mortality
Plasma antithrombin activity

Full Information

First Posted
June 27, 2011
Last Updated
March 22, 2017
Sponsor
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01384396
Brief Title
A Clinical Study of KW-3357 in Patients With DIC
Acronym
3357-005
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 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
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.

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
15 (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
Resolution from DIC by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare
Time Frame
6 days (or discontinuation)
Secondary Outcome Measure Information:
Title
DIC score
Description
Based on the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare
Time Frame
Screening, 2, 3, 4, 5, 6 days (or discontinuation)
Title
Mortality
Time Frame
28 days
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: 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
Facility Information:
City
Kanazawa
Country
Japan

12. IPD Sharing Statement

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A Clinical Study of KW-3357 in Patients With DIC

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