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

This study has been completed.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd Identifier:
First received: June 27, 2011
Last updated: June 4, 2013
Last verified: June 2013
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.

Condition Intervention Phase
Disseminated Intravascular Coagulation (DIC)
Drug: KW-3357
Drug: Plasma-derived antithrombin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study of KW-3357 Compared to Plasma-derived Antithrombin for Disseminated Intravascular Coagulation (DIC) Associated With Infection

Further study details as provided by Kyowa Hakko Kirin Co., Ltd:

Primary Outcome Measures:
  • DIC resolution
    Japanese Association for Acute Medicine-defined DIC criteria score < 4

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 200
Study Start Date: June 2011
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KW-3357 Drug: KW-3357
Intravenous infusion once a day
Active Comparator: Plasma-derived antithrombin Drug: Plasma-derived antithrombin
Intravenous infusion once a day


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  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 identifier: NCT01384903

Saga, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
  More Information

Responsible Party: Kyowa Hakko Kirin Co., Ltd Identifier: NCT01384903     History of Changes
Other Study ID Numbers: 3357-004 
Study First Received: June 27, 2011
Last Updated: June 4, 2013

Additional relevant MeSH terms:
Disseminated Intravascular Coagulation
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Antithrombin III
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants processed this record on February 27, 2017