A Clinical Study of KW-3357 in Patients With DIC

Kyowa Kirin Co., Ltd.15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Disseminated Intravascular Coagulation (DIC)

Interventions

KW-3357DRUG

Intravenous infusion once a day

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Kanazawa, Japan

Outcomes

Primary Outcomes

Safety

Number of patients with adverse events

Time frame: up to 6 days (or discontinuation)

DIC resolution

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

Time frame: 6 days (or discontinuation)

Secondary Outcomes

DIC score

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

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

Mortality

Time frame: 28 days

Plasma antithrombin activity

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

Data from ClinicalTrials.gov

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