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

This study is currently recruiting participants.
Verified August 2012 by Kyowa Hakko Kirin Company, Limited
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01384903
First received: June 27, 2011
Last updated: August 22, 2012
Last verified: August 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:
  • DIC resolution [ Designated as safety issue: No ]
    Japanese Association for Acute Medicine-defined DIC criteria score < 4


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: June 2011
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
Active Comparator: Plasma-derived antithrombin Drug: Plasma-derived antithrombin
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:

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384903

Contacts
Contact: Project Management Department clinical.info@kyowa-kirin.co.jp

Locations
Japan
Recruiting
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: NCT01384903     History of Changes
Other Study ID Numbers: 3357-004
Study First Received: June 27, 2011
Last Updated: August 22, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Disseminated Intravascular Coagulation
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Thrombophilia
Antithrombins
Antithrombin III
Antithrombin Proteins
 Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013