An Open-label Study of KW-3357

Disseminated Intravascular Coagulation (DIC) Clinical Trial

— 3357-004  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01384903
• Other study ID #: 3357-004
• Status: Completed
• Phase: Phase 3
• First received: June 27, 2011
• Last updated: March 22, 2017
• Start date: June 2011
• Est. completion date: May 2013

Study information

• Verified date: March 2017
• Source: Kyowa Hakko Kirin Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disseminated Intravascular Coagulation
• Disseminated Intravascular Coagulation (DIC)

Intervention

Drug:
• KW-3357
Intravenous infusion once a day
• Plasma-derived antithrombin
Intravenous infusion once a day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

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