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OpenTrials
Completed

NCT Number: NCT01384903

An Open-label Study of KW-3357

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.

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Key information

Conditions

Disseminated Intravascular Coagulation (DIC) Blood Coagulation Disorders Disseminated Intravascular Coagulation Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Thrombophilia

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Saga, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KW-3357

Drug

Intravenous infusion once a day

Plasma-derived antithrombin

Drug

Intravenous infusion once a day

Primary outcomes

  1. DIC resolution

    Time frame: 6 days (or discontinuation)

    Japanese Association for Acute Medicine-defined DIC criteria score < 4

Secondary outcomes

  1. 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

  2. Mortality

    Time frame: 28 days

  3. Organ symptoms

    Time frame: Screening, 4, 6 days (or discontinuation)

    Sepsis related organ failure assessment score

  4. Severity

    Time frame: Screening, 4, 6 days (or discontinuation)

    The Acute Physiology and Chronic Health Evaluation II score

  5. Plasma antithrombin activity

    Time frame: Screening, 2, 3, 4, 5, 6 days (or discontinuation)

  6. Number of patients with adverse events

    Time frame: up to 6 days (or discontinuation)

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

An Open-label Study of KW-3357 Compared to Plasma-derived Antithrombin for Disseminated Intravascular Coagulation (DIC) Associated With Infection

Acronym: 3357-004

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 29, 2011
Registry last updated
Mar 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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