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Investigation of Ondexxya for treating life-threatening bleeding

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

Observational AstraZeneca · NCT05454787

This study is testing how safe and effective Ondexxya is for people with life-threatening bleeding who are using Factor Xa inhibitors.

Quick facts

Study type	Observational
Enrollment	300 (estimated)
Sex	All
Sponsor	AstraZeneca Industry-sponsored
Locations	66 sites (Aichi and 65 other locations)
Trial ID	NCT05454787 on ClinicalTrials.gov

What this trial studies

This observational survey aims to collect data on the safety and effectiveness of Ondexxya, an intravenous injection used to counteract the effects of Factor Xa inhibitors in patients experiencing life-threatening bleeding. The study will monitor the occurrence of adverse drug reactions and assess factors influencing the drug's safety and effectiveness in real-world settings. By gathering this information, the study seeks to enhance understanding of Ondexxya's performance under actual use conditions.

Who should consider this trial

Good fit: Ideal candidates for this study are patients who have been treated with Ondexxya during a life-threatening or unarrestable bleeding episode.

Not a fit: Patients not experiencing life-threatening bleeding or those not treated with Ondexxya will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of Ondexxya, potentially improving treatment outcomes for patients with life-threatening bleeding.

How similar studies have performed: While this study focuses on real-world data collection, similar observational studies have shown success in understanding drug safety and effectiveness in various contexts.

Eligibility criteria

Show full inclusion / exclusion criteria

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

Where this trial is running

Aichi and 65 other locations

Research Site — Aichi, Japan (Withdrawn)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Research Site — Akita, Japan (Withdrawn)
Research Site — Aomori, Japan (Withdrawn)
Research Site — Chiba, Japan (Withdrawn)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 — Fukui, Japan (Active_not_recruiting)
Research Site — Fukuoka, Japan (Withdrawn)
Research Site — Fukuoka, Japan (Active_not_recruiting)
Research Site — Fukushima, Japan (Withdrawn)
Research Site — Gifu, Japan (Withdrawn)
Research Site — Gifu, Japan (Active_not_recruiting)
Research Site — Gunma, Japan (Withdrawn)
Research Site — Gunma, Japan (Active_not_recruiting)
Research Site — Gunma, Japan (Recruiting)
Research Site — Hiroshima, Japan (Withdrawn)
Research Site — Hokkaido, Japan (Withdrawn)
Research Site — Hokkaido, Japan (Active_not_recruiting)
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 — Kumamoto, Japan (Active_not_recruiting)
Research Site — Kyoto, Japan (Withdrawn)
Research Site — Mie, Japan (Withdrawn)
Research Site — Mie, Japan (Active_not_recruiting)
Research Site — Miyagi, Japan (Withdrawn)
Research Site — Miyazaki, Japan (Withdrawn)
Research Site — Nagano, Japan (Withdrawn)
Research Site — Nagano, Japan (Active_not_recruiting)
Research Site — Nagasaki, Japan (Withdrawn)
Research Site — Nagasaki, Japan (Recruiting)
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)
Research Site — Osaka, Japan (Active_not_recruiting)
Research Site — Saga, Japan (Withdrawn)
Research Site — Saitama, Japan (Withdrawn)

+16 more sites — see ClinicalTrials.gov for the full list.

Study contacts

Study coordinator: AstraZeneca Clinical Study Information Center
Email: information.center@astrazeneca.com
Phone: 1-877-240-9479

How to participate

Review the eligibility criteria above with your treating physician.
Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov → Find more trials like this →

Conditions Life Threatening Bleeding Factor Xa Inhibitor

Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.