Specified Drug Use-Results Survey on "ACOALAN for DIC "

Specified Drug Use-Results Survey on "ACOALAN for DIC " - Specified Drug Use-Results Survey on "ACOALAN for DIC "

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050277

Enrollment

1500

Registered

2023-02-08

Start date

2016-04-01

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Antithrombin decreased DIC patients who received ACOALAN for DIC normal use Antithrombin decreased DIC patients who received ACOALAN for DIC emergency use

Exclusion criteria

Exclusion criteria: When the contract is not concluded When the number of contract cases has been reached If the administration start date is out of the contract period For already registered patients When more than 6 days have elapsed from the administration start date on normal DIC treatment arm. Regardless of the number of days elapse, patients on high dose treatment arm can be recruited. Patients used for diseases other than approved efficacy benefits

Design outcomes

Primary

Measure	Time frame
Safety 1.Development of ADR/infectious diseases (type, incident rate, etc.) 2.Investigation of factors considered to affect safety 3.Status of serious adverse events Effectiveness 1.Effective rate 2.Examination of factors considered to affect the effectiveness	—

Countries

Japan

Contacts

Public ContactHoriguchi Shuji

Kyowa Kirin Co., Ltd. Pharmacovigilance Division

umin_acoa.sb@kyowakirin.com03-5205-7200

Outcome results