A Phase 3 Clinical Study of KW-3357 in Patients With DIC

Disseminated Intravascular Coagulation (DIC) Clinical Trial

— 3357-006  

Official title:

A Clinical Study of KW-3357 in Patients Diagnosed as Disseminated Intravascular Coagulation (DIC) by Japanese Association for Acute Medicine-defined DIC Criteria

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01384409
• Other study ID #: 3357-006
• Status: Terminated
• Phase: Phase 3
• First received: June 27, 2011
• Last updated: March 22, 2017
• Start date: February 2012
• Est. completion date: October 2012

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

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 Japanese Association for Acute Medicine-defined DIC criteria.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion 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

• Possibility for the promotion of bleeding by concomitant use of heparin

Related Conditions & MeSH terms

• Disseminated Intravascular Coagulation
• Disseminated Intravascular Coagulation (DIC)

Intervention

Drug:
• KW-3357
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	Safety	Number of patients with adverse events	up to 6 days (or discontinuation)
Primary	DIC resolution	Japanese Association for Acute Medicine-defined DIC criteria score < 4	6 days (or discontinuation)
Primary	DIC score	Based on the Japanese Association for Acute Medicine-defined DIC criteria	Screening, 2, 3, 4, 5, 6 days (or discontinuation)
Primary	Mortality		28 days
Primary	Organ symptoms	Sepsis related organ failure assessment score	Screening, 4, 6 days (or discontinuation)
Primary	Severity	The Acute Physiology and Chronic Health Evaluation II score	Screening, 4, 6 days (or discontinuation)
Primary	Plasma antithrombin activity		Screening, 2, 3, 4, 5, 6 days (or discontinuation)