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New drug studied to reverse blood thinners during emergency bleeding

NCT ID NCT05454787

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This study tracks the safety and effectiveness of Ondexxya, a drug that reverses the effects of certain blood thinners (apixaban, rivaroxaban, or edoxaban) during life-threatening or unstoppable bleeding. Researchers will monitor 300 patients for side effects and how well the drug works in real-world use. The goal is to better understand the drug's risks and benefits in emergency situations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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. The patients treated with direct acting Factor Xa inhibitors (apixaban, rivaroxaban or edoxaban tosilate hydrate) to neutralize anticoagulation effect at the time of life threatening bleeding or uncontrolled bleeding during the period of ethical free provision of the drug ( from the date of market authorization to the date of NHI drug price listing ) are also included.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Factor xa inhibitor Life threatening bleeding

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    WITHDRAWN

    Aichi, Japan

  • Research Site

    RECRUITING

    Aichi, Japan

  • Research Site

    WITHDRAWN

    Akita, Japan

  • Research Site

    WITHDRAWN

    Aomori, Japan

  • Research Site

    WITHDRAWN

    Chiba, Japan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Chiba, Japan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Ehime, Japan

  • Research Site

    WITHDRAWN

    Ehime, Japan

  • Research Site

    WITHDRAWN

    Fukui, Japan

  • Research Site

    WITHDRAWN

    Fukuoka, Japan

  • Research Site

    WITHDRAWN

    Fukushima, Japan

  • Research Site

    WITHDRAWN

    Gifu, Japan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Gifu, Japan

  • Research Site

    WITHDRAWN

    Gunma, Japan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Hiroshima, Japan

  • Research Site

    WITHDRAWN

    Hiroshima, Japan

  • Research Site

    WITHDRAWN

    Hokkaido, Japan

  • Research Site

    WITHDRAWN

    Hyōgo, Japan

  • Research Site

    WITHDRAWN

    Ibaraki, Japan

  • Research Site

    WITHDRAWN

    Ishikawa, Japan

  • Research Site

    WITHDRAWN

    Kagawa, Japan

  • Research Site

    WITHDRAWN

    Kagoshima, Japan

  • Research Site

    WITHDRAWN

    Kanagawa, Japan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Kanagawa, Japan

  • Research Site

    WITHDRAWN

    Kochi, Japan

  • Research Site

    WITHDRAWN

    Kumamoto, Japan

  • Research Site

    WITHDRAWN

    Kyoto, Japan

  • Research Site

    WITHDRAWN

    Mie, Japan

  • Research Site

    WITHDRAWN

    Miyagi, Japan

  • Research Site

    WITHDRAWN

    Miyazaki, Japan

  • Research Site

    WITHDRAWN

    Nagano, Japan

  • Research Site

    WITHDRAWN

    Nagasaki, Japan

  • Research Site

    WITHDRAWN

    Nara, Japan

  • Research Site

    WITHDRAWN

    Niigata, Japan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Niigata, Japan

  • Research Site

    WITHDRAWN

    Numakunai, Japan

  • Research Site

    WITHDRAWN

    Okayama, Japan

  • Research Site

    WITHDRAWN

    Okinawa, Japan

  • Research Site

    WITHDRAWN

    Osaka, Japan

  • Research Site

    WITHDRAWN

    Saga, Japan

  • Research Site

    WITHDRAWN

    Saitama, Japan

  • Research Site

    WITHDRAWN

    Shiga, Japan

  • Research Site

    WITHDRAWN

    Shimane, Japan

  • Research Site

    WITHDRAWN

    Shizuoka, Japan

  • Research Site

    WITHDRAWN

    Tochigi, Japan

  • Research Site

    WITHDRAWN

    Tokushima, Japan

  • Research Site

    WITHDRAWN

    Tokyo, Japan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Tottori, Japan

  • Research Site

    WITHDRAWN

    Toyama, Japan

  • Research Site

    WITHDRAWN

    Wakayama, Japan

  • Research Site

    WITHDRAWN

    Yamagata, Japan

  • Research Site

    WITHDRAWN

    Yamaguchi, Japan

  • Research Site

    WITHDRAWN

    Yamanashi, Japan

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