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An Open-label Study of KW-3357 (3357-004)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier:
NCT01384903
First received: June 27, 2011
Last updated: March 22, 2017
Last verified: March 2017

June 27, 2011
March 22, 2017
June 2011
May 2013   (Final data collection date for primary outcome measure)
DIC resolution [ Time Frame: 6 days (or discontinuation) ]
Japanese Association for Acute Medicine-defined DIC criteria score < 4
DIC resolution
Japanese Association for Acute Medicine-defined DIC criteria score < 4
Complete list of historical versions of study NCT01384903 on ClinicalTrials.gov Archive Site
  • DIC score [ Time Frame: Screening, 2, 3, 4, 5, 6 days (or discontinuation) ]
    Based on the Japanese Association for Acute Medicine-defined DIC criteria score
  • 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) ]
  • Number of patients with adverse events [ Time Frame: up to 6 days (or discontinuation) ]
  • DIC score
    Based on the Japanese Association for Acute Medicine-defined DIC criteria score
  • Mortality
  • Organ symptoms
    Sepsis related organ failure assessment score
  • Severity
    The Acute Physiology and Chronic Health Evaluation II score
  • Plasma antithrombin activity
  • Number of patients with adverse events
Not Provided
Not Provided
 
An Open-label Study of KW-3357
An Open-label Study of KW-3357 Compared to Plasma-derived Antithrombin for Disseminated Intravascular Coagulation (DIC) Associated With Infection
The purpose of this study is to evaluate the efficacy and safety of KW-3357 compared to plasma-derived antithrombin using multi-center, open-label, parallel-group, comparative method in patients with Disseminated Intravascular Coagulation (DIC) associated with infection.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Disseminated Intravascular Coagulation (DIC)
  • Drug: KW-3357
    Intravenous infusion once a day
  • Drug: Plasma-derived antithrombin
    Intravenous infusion once a day
  • Experimental: KW-3357
    Intervention: Drug: KW-3357
  • Active Comparator: Plasma-derived antithrombin
    Intervention: Drug: Plasma-derived antithrombin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
221
May 2013
May 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Meet the ACCP/SCCM-defined sepsis 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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01384903
3357-004
Not Provided
Not Provided
Not Provided
Not Provided
Kyowa Hakko Kirin Co., Ltd
Kyowa Hakko Kirin Co., Ltd
Not Provided
Not Provided
Kyowa Hakko Kirin Co., Ltd
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP