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A phase III study of KW-3357

An open-label study of KW-3357 compared to plasma-derived antithrombin for disseminated intravascular coagulation (DIC) associated with infection

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221494
Enrollment
Unknown
Registered
2011-06-28
Start date
2011-06-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disseminated intravascular coagulation (DIC)

Interventions

investigational material(s) Generic name etc : KW-3357 INN of investigational material : Therapeutic category code : 634 Human blood preparations Dosage and Administration for Investigational materia

Sponsors

Kyowa Hakko Kirin Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
DIC resolution—

Secondary

MeasureTime frame
DIC score Mortality Organ symptoms Severity Plasma antithrombin activity Safety—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026