An Open-label Study of KW-3357

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.
• Treatments: Antithrombin III; Antithrombins

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