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Completed

NCT Number: NCT01384396

A Clinical Study of KW-3357 in Patients With DIC

To evaluate the efficacy and safety of KW-3357 with concomitant use of heparin using multi-center, non-comparative, open-label method in patients diagnosed as disseminated intravascular coagulation (DIC) by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare.

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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

Kanazawa, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed or suspected as DIC by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare
  • 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
  • Possibility for the promotion of bleeding by concomitant use of heparin

Treatment and study plan

KW-3357

Drug

Intravenous infusion once a day

Primary outcomes

  1. Safety

    Time frame: up to 6 days (or discontinuation)

    Number of patients with adverse events

  2. DIC resolution

    Time frame: 6 days (or discontinuation)

    Resolution from DIC by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare

Secondary outcomes

  1. DIC score

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

    Based on the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare

  2. Mortality

    Time frame: 28 days

  3. Plasma antithrombin activity

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

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

A Clinical Study of KW-3357 in Patients Diagnosed as Disseminated Intravascular Coagulation (DIC) by the Diagnostic Criteria for DIC Established by the Japanese Ministry of Health and Welfare

Acronym: 3357-005

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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