Recruiting NCT05454787

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

— Observational Life Threatening Bleeding Factor Xa Inhibitor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Life Threatening Bleeding, Factor Xa Inhibitor. Basic parameters: No limits · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Japan
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

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

Primary outcome measures

Incidence of adverse drug reactions, Incidence of safety specifications, Incidence of adverse drug reactions by patient background factor [Time frame: 30days]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

Japan · 61 centers

Research Site — Aichi
Research Site — Aichi
Research Site — Akita
Research Site — Aomori
Research Site — Chiba
Research Site — Chiba
Research Site — Ehime
Research Site — Ehime
… and 53 more centers

Identifiers

NCT: NCT05454787 · D9603C00001

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗