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Clinical Trials in Japan / NCT05454787
Recruiting Observational

Ondexxya for Intravenous Injection 200mg Drug Use Result Investigation (All Case Investigation)

NCT05454787 · tracked via the Priya Life Science Japan tracker
Sponsor
AstraZeneca
Phase
Observational
Started
2022-06-02
Last updated
2026-10-13

Condition(s) studied

Life Threatening BleedingFactor Xa Inhibitor

Study summary

This survey will be conducted to investigate the status of occurrence of the safety specifications set for "Safety specification" in patients who received Ondexxya Intravenous Injection 200 mg. In addition, this survey will be implemented to understand the followings by collecting safety and effectiveness information under actual use conditions.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * All patients treated with this drug to neutralize the anticoagulant effect of a FXa inhibitor (apixaban, rivaroxaban, or edoxaban) at onset of a life-threatening bleeding episode or a unarrestable bleeding episode. Exclusion Criteria: * N/A

Primary outcome measure(s)

  • Incidence of adverse drug reactions, Incidence of safety specifications, Incidence of adverse drug reactions by patient background factor — 30days
    Incidence of adverse drug reactions, Incidence of safety specifications, Incidence of adverse drug reactions by patient background factor

Trial sites (54)

FacilityCityRegionStatus
Research Site Aichi Japan Withdrawn
Research Site Aichi Japan Recruiting
Research Site Akita Japan Withdrawn
Research Site Aomori Japan Withdrawn
Research Site Chiba Japan Withdrawn
Research Site Chiba Japan Active Not Recruiting
Research Site Ehime Japan Active Not Recruiting
Research Site Ehime Japan Withdrawn
Research Site Fukui Japan Withdrawn
Research Site Fukuoka Japan Withdrawn
Research Site Fukushima Japan Withdrawn
Research Site Gifu Japan Withdrawn
Research Site Gifu Japan Active Not Recruiting
Research Site Gunma Japan Withdrawn
Research Site Hiroshima Japan Active Not Recruiting
Research Site Hiroshima Japan Withdrawn
Research Site Hokkaido Japan Withdrawn
Research Site Hyōgo Japan Withdrawn
Research Site Ibaraki Japan Withdrawn
Research Site Ishikawa Japan Withdrawn
Research Site Kagawa Japan Withdrawn
Research Site Kagoshima Japan Withdrawn
Research Site Kanagawa Japan Withdrawn
Research Site Kanagawa Japan Active Not Recruiting
Research Site Kochi Japan Withdrawn
Research Site Kumamoto Japan Withdrawn
Research Site Kyoto Japan Withdrawn
Research Site Mie Japan Withdrawn
Research Site Miyagi Japan Withdrawn
Research Site Miyagi Japan Active Not Recruiting
Research Site Miyazaki Japan Withdrawn
Research Site Nagano Japan Withdrawn
Research Site Nagasaki Japan Withdrawn
Research Site Nara Japan Withdrawn
Research Site Niigata Japan Withdrawn
Research Site Niigata Japan Active Not Recruiting
Research Site Numakunai Japan Withdrawn
Research Site Okayama Japan Withdrawn
Research Site Okinawa Japan Withdrawn
Research Site Osaka Japan Withdrawn

+ 14 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05454787 on ClinicalTrials.gov ↗ ← All trials in Japan