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

Recruiting now

Conditions studied: Life Threatening Bleeding, Factor Xa Inhibitor

In brief

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.

Key facts

Study ID: NCT05454787
Run by: AstraZeneca
People needed: 300
Starts: 2022-06-02
Expected to finish: 2026-10-31
Last updated by the study team: 2026-07-28

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

Where it is running

Research Site — Gunma, Japan (enrolling)
Research Site — Aichi, Japan (enrolling)
Research Site — Akita, Japan
Research Site — Chiba, Japan
Research Site — Chiba, Japan
Research Site — Ehime, Japan
Research Site — Fukui, Japan
Research Site — Gunma, Japan
Research Site — Fukui, Japan
Research Site — Fukuoka, Japan
Research Site — Fukuoka, Japan
Research Site — Fukushima, Japan
Research Site — Gifu, Japan
Research Site — Gifu, Japan
Research Site — Gunma, Japan
Research Site — Ehime, Japan
Research Site — Aomori, Japan
Research Site — Hiroshima, Japan
Research Site — Hokkaido, Japan
Research Site — Hokkaido, Japan
Research Site — Hyōgo, Japan
Research Site — Ibaraki, Japan
Research Site — Ishikawa, Japan
Research Site — Kagawa, Japan
Research Site — Aichi, Japan

Full record on ClinicalTrials.gov

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