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
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, see Learn About Clinical Studies.

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 July 31, 2014