A postmarketing clinical study on ART-123 in patients with DIC caused by solid tumor
Phase 4
- Conditions
- Disseminated intravascular coagulation (DIC) directly caused by solid tumor
- Registration Number
- JPRN-jRCT1080220847
- Lead Sponsor
- ASAHI KASEI PHARMA CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 100
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
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DIC restoration
- Secondary Outcome Measures
Name Time Method Incidence rate of adverse events related to hemorrhage symptoms, Course of hemorrhage symptoms, Rate of improvement of blood clotting test findings, Outcome of subjects