An Open-label Study of KW-3357 (3357-004)

March 22, 2017 updated by: Kyowa Kirin Co., Ltd.

An Open-label Study of KW-3357 Compared to Plasma-derived Antithrombin for Disseminated Intravascular Coagulation (DIC) Associated With Infection

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

221

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

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:

  • 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

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: KW-3357
Drug: KW-3357
Intravenous infusion once a day
ACTIVE_COMPARATOR: Plasma-derived antithrombin
Drug: Plasma-derived antithrombin
Intravenous infusion once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DIC resolution
Time Frame: 6 days (or discontinuation)
Japanese Association for Acute Medicine-defined DIC criteria score < 4
6 days (or discontinuation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 28 days
28 days
Organ symptoms
Time Frame: Screening, 4, 6 days (or discontinuation)
Sepsis related organ failure assessment score
Screening, 4, 6 days (or discontinuation)
Severity
Time Frame: Screening, 4, 6 days (or discontinuation)
The Acute Physiology and Chronic Health Evaluation II score
Screening, 4, 6 days (or discontinuation)
Plasma antithrombin activity
Time Frame: Screening, 2, 3, 4, 5, 6 days (or discontinuation)
Screening, 2, 3, 4, 5, 6 days (or discontinuation)
DIC score
Time Frame: Screening, 2, 3, 4, 5, 6 days (or discontinuation)
Based on the Japanese Association for Acute Medicine-defined DIC criteria score
Screening, 2, 3, 4, 5, 6 days (or discontinuation)
Number of patients with adverse events
Time Frame: up to 6 days (or discontinuation)
up to 6 days (or discontinuation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2011

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 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

  • 3357-004

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.

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