NCT05454787

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

66 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Jun 2022Aug 2026

Study Start

First participant enrolled

June 2, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

4.2 years

First QC Date

July 7, 2022

Last Update Submit

May 4, 2026

Conditions

Life Threatening BleedingFactor Xa Inhibitor

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse drug reactions, Incidence of safety specifications, Incidence of adverse drug reactions by patient background factor

    Incidence of adverse drug reactions, Incidence of safety specifications, Incidence of adverse drug reactions by patient background factor

    30days

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (66)

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

Research Site

Shiga, Japan

WITHDRAWN

Research Site

Shimane, Japan

WITHDRAWN

Research Site

Shizuoka, Japan

WITHDRAWN

Research Site

Tochigi, Japan

WITHDRAWN

Research Site

Tochigi, Japan

ACTIVE NOT RECRUITING

Research Site

Tokushima, Japan

WITHDRAWN

Research Site

Tokyo, Japan

WITHDRAWN

Research Site

Tokyo, Japan

ACTIVE NOT RECRUITING

Research Site

Tottori, Japan

ACTIVE NOT RECRUITING

Research Site

Toyama, Japan

WITHDRAWN

Research Site

Wakayama, Japan

WITHDRAWN

Research Site

Wakayama, Japan

ACTIVE NOT RECRUITING

Research Site

Yamagata, Japan

WITHDRAWN

Research Site

Yamagata, Japan

ACTIVE NOT RECRUITING

Research Site

Yamaguchi, Japan

WITHDRAWN

Research Site

Yamanashi, Japan

WITHDRAWN

Study Officials

  • Toshimitsu Tokimoto

    Astrazeneca KK

    STUDY DIRECTOR

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479information.center@astrazeneca.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2022

First Posted

July 12, 2022

Study Start

June 2, 2022

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

May 5, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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.

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.
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.
More information

Locations

JP(66)