NCT05454787 Ondexxya for Intravenous Injection 200mg Drug Use Result Investigation (All Case Investigation)
| NCT ID | NCT05454787 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AstraZeneca |
| Condition | Life Threatening Bleeding |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-06-02 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2022-06-02 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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: * N/A
Contact & Investigator
Toshimitsu Tokimoto
STUDY DIRECTOR
Astrazeneca KK
Frequently Asked Questions
Who can join the NCT05454787 clinical trial?
This trial is open to participants of all sexes, studying Life Threatening Bleeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05454787 currently recruiting?
Yes, NCT05454787 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT05454787 trial being conducted?
This trial is being conducted at Aichi, Japan, Aichi, Japan, Akita, Japan, Aomori, Japan and 11 additional locations.
Who is sponsoring the NCT05454787 clinical trial?
NCT05454787 is sponsored by AstraZeneca. The principal investigator is Toshimitsu Tokimoto at Astrazeneca KK. The trial plans to enroll 300 participants.