A Clinical Study of KW-3357 in Patients With DIC (3357-005)

Kyowa Kirin

Status and phase: Completed; Phase 3

Conditions: Disseminated Intravascular Coagulation (DIC)

Treatments: Drug: KW-3357

Study type: Interventional

Funder types: Industry

Identifiers

NCT01384396

3357-005

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

KW-3357

Experimental group

Treatment:

Drug: KW-3357