Clinical trial Recruiting at 1 site Observational

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.

More Factor Xa Inhibitor trials

Quick facts

Study typeObservational
SexAll
Enrollment300 (estimated)
SponsorAstraZeneca
Industry-sponsored
Locations54 sites (Aichi and 53 other locations)
StatusRecruiting
StartedJune 2, 2022
Main results expectedOctober 31, 2026
Study endsOctober 31, 2026
Registry record updatedOctober 13, 2026
Trial IDNCT05454787 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

  • Research Site
    Aichi, Japan
    Recruiting
  • Research Site
    Aichi, Japan
    Withdrawn
  • Research Site
    Akita, Japan
    Withdrawn
  • Research Site
    Aomori, Japan
    Withdrawn
  • Research Site
    Chiba, Japan
    Withdrawn
  • Research Site
    Chiba, Japan
    Active not recruiting
Show 44 more locations
  • 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
  • Research Site
    Saga, Japan
    Withdrawn
  • Research Site
    Saitama, Japan
    Withdrawn
  • Research Site
    Shiga, Japan
    Withdrawn
  • Research Site
    Shimane, Japan
    Withdrawn
  • Research Site
    Shizuoka, Japan
    Withdrawn
  • Research Site
    Tochigi, Japan
    Withdrawn
  • Research Site
    Tokushima, Japan
    Withdrawn
  • Research Site
    Tokyo, Japan
    Withdrawn
  • Research Site
    Tottori, Japan
    Active not recruiting
  • Research Site
    Toyama, Japan
    Withdrawn

+4 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.