A Clinical Study of KW-3357 in Patients With DIC

NCT ID: NCT01384396

Last Updated: 2017-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Disseminated Intravascular Coagulation (DIC)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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KW-3357

Group Type EXPERIMENTAL

KW-3357

Intervention Type DRUG

Intravenous infusion once a day

Interventions

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KW-3357

Intravenous infusion once a day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kanazawa, , Japan

Site Status

Countries

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Japan

Other Identifiers

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3357-005

Identifier Type: -

Identifier Source: org_study_id

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