An Open-label Study of KW-3357 (3357-004)

Kyowa Kirin

Status and phase: Completed; Phase 3

Conditions: Disseminated Intravascular Coagulation (DIC)

Treatments: Drug: Plasma-derived antithrombin; Drug: KW-3357

Study type: Interventional

Funder types: Industry

Identifiers

NCT01384903

3357-004

Details and patient eligibility

About

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.

Enrollment: 221 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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221 participants in 2 patient groups

KW-3357

Experimental group

Treatment:

Drug: KW-3357

Plasma-derived antithrombin

Active Comparator group

Treatment:

Drug: Plasma-derived antithrombin