Clinical Trial: An Open-label Study of KW-3357

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Kyowa Hakko Kirin Co., Ltd

Current Primary Outcome: DIC resolution [ Time Frame: 6 days (or discontinuation) ]

Original Primary Outcome: DIC resolution

Current Secondary Outcome:

• 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) ]

Original Secondary Outcome:

• 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

Information By: Kyowa Hakko Kirin Co., Ltd

Dates:
Date Received: June 27, 2011
Date Started: June 2011
Date Completion:
Last Updated: March 22, 2017
Last Verified: March 2017