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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01384396
First received: June 27, 2011
Last updated: April 24, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Disseminated Intravascular Coagulation (DIC)
 Drug: KW-3357
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
    Number of patients with adverse events

  • DIC resolution [ Designated as safety issue: No ]
    Resolution from DIC by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare


Secondary Outcome Measures:
  • DIC score [ Designated as safety issue: No ]
    Based on the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare

  • Mortality [ Designated as safety issue: No ]
  • Plasma antithrombin activity [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: December 2011
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KW-3357 Drug: KW-3357
Intravenous infusion once a day

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384396

Locations
Japan
Kanazawa, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT01384396     History of Changes
Other Study ID Numbers: 3357-005
Study First Received: June 27, 2011
Last Updated: April 24, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Disseminated Intravascular Coagulation
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Thrombophilia

ClinicalTrials.gov processed this record on May 19, 2013