Clinical Trial: A Phase 3 Clinical Study of KW-3357 in Patients With DIC

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Japanese Association for Acute Medicine-defined DIC criteria.

Detailed Summary:
Sponsor: Kyowa Hakko Kirin Co., Ltd

Current Primary Outcome:

  • Safety [ Time Frame: up to 6 days (or discontinuation) ]
    Number of patients with adverse events
  • DIC resolution [ Time Frame: 6 days (or discontinuation) ]
    Japanese Association for Acute Medicine-defined DIC criteria score < 4
  • DIC score [ Time Frame: Screening, 2, 3, 4, 5, 6 days (or discontinuation) ]
    Based on the Japanese Association for Acute Medicine-defined DIC criteria
  • Mortality [ Time Frame: 28 days ]
  • Organ symptoms [ Time Frame: Screening, 4, 6 days (or discontinuation) ]
    Sepsis related organ failure assessment score
  • Severity [ Time Frame: Screening, 4, 6 days (or discontinuation) ]
    The Acute Physiology and Chronic Health Evaluation II score
  • Plasma antithrombin activity [ Time Frame: Screening, 2, 3, 4, 5, 6 days (or discontinuation) ]


Original Primary Outcome:

  • Safety
    Number of patients with adverse events
  • DIC resolution
    Japanese Association for Acute Medicine-defined DIC criteria score < 4
  • DIC score
    Based on the Japanese Association for Acute Medicine-defined DIC criteria
  • Mortality
  • Organ symptoms
    Sepsis related organ failure assessment score
  • Severity
    The Acute Physiology and Chronic Health Evaluation II score
  • Plasma antithrombin activity


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Kyowa Hakko Kirin Co., Ltd

Dates:
Date Received: June 27, 2011
Date Started: February 2012
Date Completion:
Last Updated: March 22, 2017
Last Verified: March 2017