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

May 25, 2026 updated by: AstraZeneca
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

  1. Detection of unknown adverse drug reactions
  2. Incidence of adverse drug reactions under actual use conditions of the drug
  3. Factors that may affect the safety or effectiveness

"Safety specification" Thrombotic events, Infusion reaction, re-bleeding

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Aichi, Japan
        • Recruiting
        • Research Site
      • Aichi, Japan
        • Withdrawn
        • Research Site
      • Akita, Japan
        • Withdrawn
        • Research Site
      • Aomori, Japan
        • Withdrawn
        • Research Site
      • Chiba, Japan
        • Active, not recruiting
        • Research Site
      • Chiba, Japan
        • Withdrawn
        • Research Site
      • Ehime, Japan
        • Active, not recruiting
        • Research Site
      • Ehime, Japan
        • Withdrawn
        • Research Site
      • Fukui, Japan
        • Active, not recruiting
        • Research Site
      • Fukui, Japan
        • Withdrawn
        • Research Site
      • Fukuoka, Japan
        • Active, not recruiting
        • Research Site
      • Fukuoka, Japan
        • Withdrawn
        • Research Site
      • Fukushima, Japan
        • Withdrawn
        • Research Site
      • Gifu, Japan
        • Active, not recruiting
        • Research Site
      • Gifu, Japan
        • Withdrawn
        • Research Site
      • Gunma, Japan
        • Recruiting
        • Research Site
      • Gunma, Japan
        • Active, not recruiting
        • Research Site
      • Gunma, Japan
        • Withdrawn
        • Research Site
      • Hiroshima, Japan
        • Withdrawn
        • Research Site
      • Hokkaido, Japan
        • Active, not recruiting
        • 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
      • Kochi, Japan
        • Withdrawn
        • Research Site
      • Kumamoto, Japan
        • Active, not recruiting
        • Research Site
      • Kumamoto, Japan
        • Withdrawn
        • Research Site
      • Kyoto, Japan
        • Withdrawn
        • Research Site
      • Mie, Japan
        • Active, not recruiting
        • Research Site
      • Mie, Japan
        • Withdrawn
        • Research Site
      • Miyagi, Japan
        • Withdrawn
        • Research Site
      • Miyazaki, Japan
        • Withdrawn
        • Research Site
      • Nagano, Japan
        • Active, not recruiting
        • Research Site
      • Nagano, Japan
        • Withdrawn
        • Research Site
      • Nagasaki, Japan
        • Recruiting
        • Research Site
      • Nagasaki, Japan
        • Withdrawn
        • Research Site
      • Nara, Japan
        • Withdrawn
        • Research Site
      • Niigata, Japan
        • Active, not recruiting
        • Research Site
      • Niigata, Japan
        • Withdrawn
        • Research Site
      • Numakunai, Japan
        • Withdrawn
        • Research Site
      • Okayama, Japan
        • Withdrawn
        • Research Site
      • Okinawa, Japan
        • Withdrawn
        • Research Site
      • Osaka, Japan
        • Active, not recruiting
        • 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
        • Active, not recruiting
        • Research Site
      • Tochigi, Japan
        • Withdrawn
        • Research Site
      • Tokushima, Japan
        • Withdrawn
        • Research Site
      • Tokyo, Japan
        • Active, not recruiting
        • Research Site
      • Tokyo, Japan
        • Withdrawn
        • Research Site
      • Tottori, Japan
        • Active, not recruiting
        • Research Site
      • Toyama, Japan
        • Withdrawn
        • Research Site
      • Wakayama, Japan
        • Active, not recruiting
        • Research Site
      • Wakayama, Japan
        • Withdrawn
        • Research Site
      • Yamagata, Japan
        • Active, not recruiting
        • Research Site
      • Yamagata, Japan
        • Withdrawn
        • Research Site
      • Yamaguchi, Japan
        • Withdrawn
        • Research Site
      • Yamanashi, Japan
        • Withdrawn
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse drug reactions, Incidence of safety specifications, Incidence of adverse drug reactions by patient background factor
Time Frame: 30days
Incidence of adverse drug reactions, Incidence of safety specifications, Incidence of adverse drug reactions by patient background factor
30days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Toshimitsu Tokimoto, Astrazeneca KK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2022

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

July 7, 2022

First Submitted That Met QC Criteria

July 7, 2022

First Posted (Actual)

July 12, 2022

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • D9603C00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli Org.

Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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