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

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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 Hakko 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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) ]


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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
Japan
Kanazawa, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT01384396     History of Changes
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:
Disseminated Intravascular Coagulation
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Thrombophilia