Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01384396
Recruitment Status : Completed
First Posted : June 29, 2011
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Disseminated Intravascular Coagulation (DIC) Drug: KW-3357 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Arm Intervention/treatment
Experimental: KW-3357 Drug: KW-3357
Intravenous infusion once a day




Primary Outcome Measures :
  1. Safety [ Time Frame: up to 6 days (or discontinuation) ]
    Number of patients with adverse events

  2. DIC resolution [ Time Frame: 6 days (or discontinuation) ]
    Resolution from DIC by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare


Secondary Outcome Measures :
  1. DIC score [ Time Frame: Screening, 2, 3, 4, 5, 6 days (or discontinuation) ]
    Based on the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare

  2. Mortality [ Time Frame: 28 days ]
  3. Plasma antithrombin activity [ Time Frame: Screening, 2, 3, 4, 5, 6 days (or discontinuation) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01384396


Locations
Layout table for location information
Japan
Kanazawa, Japan
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.
Layout table for additonal information
Responsible Party: Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier: NCT01384396    
Other Study ID Numbers: 3357-005
First Posted: June 29, 2011    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Disseminated Intravascular Coagulation
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Thrombophilia