A Phase 3 Clinical Study of KW-3357 in Patients With DIC (3357-006)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01384409
First received: June 27, 2011
Last updated: April 24, 2013
Last verified: April 2013
  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 Japanese Association for Acute Medicine-defined DIC criteria.


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 Japanese Association for Acute Medicine-defined DIC Criteria

Resource links provided by NLM:


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 ]
    Japanese Association for Acute Medicine-defined DIC criteria score < 4

  • DIC score [ Designated as safety issue: No ]
    Based on the Japanese Association for Acute Medicine-defined DIC criteria

  • Mortality [ Designated as safety issue: No ]
  • Organ symptoms [ Designated as safety issue: No ]
    Sepsis related organ failure assessment score

  • Severity [ Designated as safety issue: No ]
    The Acute Physiology and Chronic Health Evaluation II score

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

Estimated Enrollment: 10
Study Start Date: February 2012
Estimated Primary Completion Date: December 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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384409

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

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT01384409     History of Changes
Other Study ID Numbers: 3357-006
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 April 17, 2014