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A postmarketing clinical study on ART-123 in patients with DIC caused by solid tumor

A postmarketing clinical study on ART-123 in patients with disseminated intravascular coagulation (DIC) directly caused by solid tumor

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1080220847
Enrollment
100
Registered
2009-09-07
Start date
2009-09-07
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) directly caused by solid tumor

Interventions

investigational material(s) Generic name etc : ART-123 INN of investigational material : Therapeutic category code : 333 Anticoagulants Dosage and Administration for Investigational material : ART-12

Sponsors

ASAHI KASEI PHARMA CORPORATION
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Patients given a diagnosis of DIC on the basis of criteria established by the DIC research group of the Ministry of Health and Welfare of Japan -Patients with DIC directly caused by solid tumor -20 years old and older

Exclusion criteria

Exclusion criteria: -Patients showing intracranial, pulmonary, gastrointestinal hemorrhage -Patients with a history of cerebrovascular disorders within the past 52 week -Patients with a history of hypersensitivity to the ingredients of ART-123 preparations -Pregnant women, nursing mothers or possibly pregnant women

Design outcomes

Primary

MeasureTime frame
DIC restoration

Secondary

MeasureTime frame
Incidence rate of adverse events related to hemorrhage symptoms, Course of hemorrhage symptoms, Rate of improvement of blood clotting test findings, Outcome of subjects

Outcome results

None listed

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