Investigation of Ondexxya for treating life-threatening bleeding
Official title: Ondexxya for Intravenous Injection 200mg Drug Use Result Investigation (All Case Investigation)
Run by AstraZeneca · NCT05454787 · Data updated 2026-11-12
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 |
|---|---|
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 54 sites (Aichi and 53 other locations) |
| Status | Recruiting |
| Started | June 2, 2022 |
| Main results expected | October 31, 2026 |
| Study ends | October 31, 2026 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT05454787 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients who have been treated with Ondexxya during a life-threatening or unarrestable bleeding episode.
✕Probably not a fit
Patients not experiencing life-threatening bleeding or those not treated with Ondexxya will likely not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this study focuses on real-world data collection, similar observational studies have shown success in understanding drug safety and effectiveness in various contexts.
Who can join: the full rules
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 it's running
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Aichi, Japan Recruiting -
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Aichi, Japan Withdrawn -
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Akita, Japan Withdrawn -
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Aomori, Japan Withdrawn -
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Chiba, Japan Withdrawn -
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Chiba, Japan Active not recruiting
Show 44 more locations
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Ehime, Japan Active not recruiting -
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Ehime, Japan Withdrawn -
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Fukui, Japan Withdrawn -
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Fukuoka, Japan Withdrawn -
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Fukushima, Japan Withdrawn -
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Gifu, Japan Withdrawn -
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Gifu, Japan Active not recruiting -
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Gunma, Japan Withdrawn -
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Hiroshima, Japan Active not recruiting -
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Hiroshima, Japan Withdrawn -
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Hokkaido, Japan Withdrawn -
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Hyōgo, Japan Withdrawn -
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Ibaraki, Japan Withdrawn -
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Ishikawa, Japan Withdrawn -
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Kagawa, Japan Withdrawn -
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Kagoshima, Japan Withdrawn -
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Kanagawa, Japan Withdrawn -
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Kanagawa, Japan Active not recruiting -
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Kochi, Japan Withdrawn -
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Kumamoto, Japan Withdrawn -
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Kyoto, Japan Withdrawn -
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Mie, Japan Withdrawn -
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Miyagi, Japan Withdrawn -
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Miyagi, Japan Active not recruiting -
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Miyazaki, Japan Withdrawn -
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Nagano, Japan Withdrawn -
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Nagasaki, Japan Withdrawn -
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Nara, Japan Withdrawn -
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Niigata, Japan Withdrawn -
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Niigata, Japan Active not recruiting -
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Numakunai, Japan Withdrawn -
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Okayama, Japan Withdrawn -
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Okinawa, Japan Withdrawn -
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Osaka, Japan Withdrawn -
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Saga, Japan Withdrawn -
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Saitama, Japan Withdrawn -
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Shiga, Japan Withdrawn -
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Shimane, Japan Withdrawn -
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Shizuoka, Japan Withdrawn -
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Tochigi, Japan Withdrawn -
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Tokushima, Japan Withdrawn -
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Tokyo, Japan Withdrawn -
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Tottori, Japan Active not recruiting -
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Toyama, Japan Withdrawn
+4 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Thrombolysis for stroke patients on Factor Xa inhibitors
This study is testing if a common stroke treatment can safely help patients who have taken certain blood thinners in the last two days.
-
Circadian Variation of Anti-Factor Xa in Trauma Patients on LMWH
This study tests whether anti-Factor Xa levels show a daily rhythm in hospitalized trauma patients receiving LMWH for VTE prevention.
-
Effects of thickened feeds on swallowing in children with dysphagia
This study is testing if thickened liquids can help babies with swallowing problems do better when they eat.
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Effects of thickened feeds on infants with unexplained life-threatening events
This study is trying to see if giving thicker feeds to infants who have had scary unexplained events helps improve their health and reduces the need for medical care.
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Identifying life-threatening infections linked to immune system errors
This study is trying to find out how common life-threatening infections are in people with immune system problems to help doctors diagnose and treat them better.
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Understanding what makes care complex for children and young people with serious illnesses
This project tests how to define and measure complexity in the care of children and young people with life-limiting or lifethreatening conditions, by gathering input from families and health and social care professionals.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.