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

Recruiting

• Conditions: Life Threatening Bleeding; Factor Xa Inhibitor

• Registration Number: NCT05454787
• Lead Sponsor: AstraZeneca

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.

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 Timeline

• Study Start: 2022-06-02
• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions, Incidence of safety specifications, Incidence of adverse drug reactions by patient background factor	30days	Incidence of adverse drug reactions, Incidence of safety specifications, Incidence of adverse drug reactions by patient background factor

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yamanashi, Japan