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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
  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
Intervention Model: Parallel Assignment
Masking: No masking
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 [ Time Frame: 6 days (or discontinuation) ]
    Japanese Association for Acute Medicine-defined DIC criteria score < 4


Secondary Outcome Measures:
  • 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) ]

Enrollment: 221
Study Start Date: June 2011
Study Completion Date: May 2013
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

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier: NCT01384903

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

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT01384903     History of Changes
Other Study ID Numbers: 3357-004
Study First Received: June 27, 2011
Last Updated: March 22, 2017

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

ClinicalTrials.gov processed this record on May 23, 2017