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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 Company, Limited
ClinicalTrials.gov Identifier:
NCT01384903
First received: June 27, 2011
Last updated: June 4, 2013
Last verified: June 2013

June 27, 2011
June 4, 2013
June 2011
May 2013   (final data collection date for primary outcome measure)
DIC resolution [ Designated as safety issue: No ]
Japanese Association for Acute Medicine-defined DIC criteria score < 4
Same as current
Complete list of historical versions of study NCT01384903 on ClinicalTrials.gov Archive Site
  • DIC score [ Designated as safety issue: No ]
    Based on the Japanese Association for Acute Medicine-defined DIC criteria score
  • 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 ]
  • Number of patients with adverse events [ Designated as safety issue: Yes ]
Same as current
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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
200
Not Provided
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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01384903
3357-004
Not Provided
Kyowa Hakko Kirin Company, Limited
Kyowa Hakko Kirin Company, Limited
Not Provided
Not Provided
Kyowa Hakko Kirin Company, Limited
June 2013

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