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

Last updated: March 9, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05454787
D9603C00001
  • All Genders

Study 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

Inclusion Criteria:

  • All patients treated with this drug to neutralize the anticoagulant effect of a FXainhibitor (apixaban, rivaroxaban, or edoxaban) at onset of a life-threateningbleeding episode or a unarrestable bleeding episode.

Exclusion

Exclusion Criteria:

  • N/A

Study Design

Total Participants: 300
Study Start date:
June 02, 2022
Estimated Completion Date:
August 31, 2026

Study 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

Connect with a study center

  • Research Site

    Aichi,
    Japan

    Active - Recruiting

  • Research Site

    Aichi 11192139,
    Japan

    Site Not Available

  • Research Site

    Akita,
    Japan

    Site Not Available

  • Research Site

    Akita 2113126,
    Japan

    Site Not Available

  • Research Site

    Aomori,
    Japan

    Site Not Available

  • Research Site

    Aomori 2130658,
    Japan

    Site Not Available

  • Research Site

    Chiba,
    Japan

    Site Not Available

  • Research Site

    Chiba 2113015,
    Japan

    Site Not Available

  • Research Site

    Ehime,
    Japan

    Site Not Available

  • Research Site

    Fukui,
    Japan

    Site Not Available

  • Research Site

    Fukui 1863986,
    Japan

    Site Not Available

  • Research Site

    Fukuoka,
    Japan

    Site Not Available

  • Research Site

    Fukuoka 1863967,
    Japan

    Site Not Available

  • Research Site

    Fukushima,
    Japan

    Site Not Available

  • Research Site

    Fukushima 2112923,
    Japan

    Site Not Available

  • Research Site

    Gifu,
    Japan

    Site Not Available

  • Research Site

    Gifu 1863641,
    Japan

    Site Not Available

  • Research Site

    Gunma,
    Japan

    Site Not Available

  • Research Site

    Hiroshima,
    Japan

    Site Not Available

  • Research Site

    Hiroshima 1862415,
    Japan

    Site Not Available

  • Research Site

    Hokkaido,
    Japan

    Site Not Available

  • Research Site

    Hyogo,
    Japan

    Site Not Available

  • Research Site

    Hyōgo,
    Japan

    Site Not Available

  • Research Site

    Hyōgo 2129969,
    Japan

    Site Not Available

  • Research Site

    Ibaraki,
    Japan

    Site Not Available

  • Research Site

    Ibaraki 1862033,
    Japan

    Site Not Available

  • Research Site

    Ishikawa,
    Japan

    Site Not Available

  • Research Site

    Ishikawa 1861393,
    Japan

    Site Not Available

  • Research Site

    Iwate,
    Japan

    Site Not Available

  • Research Site

    Kagawa,
    Japan

    Site Not Available

  • Research Site

    Kagawa 1860837,
    Japan

    Site Not Available

  • Research Site

    Kagoshima,
    Japan

    Site Not Available

  • Research Site

    Kagoshima 1860827,
    Japan

    Site Not Available

  • Research Site

    Kanagawa,
    Japan

    Site Not Available

  • Research Site

    Kanagawa 1860292,
    Japan

    Site Not Available

  • Research Site

    Kochi,
    Japan

    Site Not Available

  • Research Site

    Kochi 1859146,
    Japan

    Site Not Available

  • Research Site

    Kumamoto,
    Japan

    Site Not Available

  • Research Site

    Kumamoto 1858421,
    Japan

    Site Not Available

  • Research Site

    Kyoto,
    Japan

    Site Not Available

  • Research Site

    Kyoto 1857910,
    Japan

    Site Not Available

  • Research Site

    Mie,
    Japan

    Site Not Available

  • Research Site

    Mie 1857357,
    Japan

    Site Not Available

  • Research Site

    Miyagi,
    Japan

    Site Not Available

  • Research Site

    Miyagi 1856813,
    Japan

    Site Not Available

  • Research Site

    Miyazaki,
    Japan

    Site Not Available

  • Research Site

    Miyazaki 1856717,
    Japan

    Site Not Available

  • Research Site

    Nagano,
    Japan

    Site Not Available

  • Research Site

    Nagano 1856215,
    Japan

    Site Not Available

  • Research Site

    Nagasaki,
    Japan

    Site Not Available

  • Research Site

    Nagasaki 1856177,
    Japan

    Site Not Available

  • Research Site

    Nara,
    Japan

    Site Not Available

  • Research Site

    Nara 1855612,
    Japan

    Site Not Available

  • Research Site

    Niigata,
    Japan

    Site Not Available

  • Research Site

    Niigata 1855431,
    Japan

    Site Not Available

  • Research Site

    Numakunai,
    Japan

    Site Not Available

  • Research Site

    Numakunai 2111574,
    Japan

    Site Not Available

  • Research Site

    Okayama,
    Japan

    Site Not Available

  • Research Site

    Okayama 1854383,
    Japan

    Site Not Available

  • Research Site

    Okinawa,
    Japan

    Site Not Available

  • Research Site

    Okinawa 1894616,
    Japan

    Site Not Available

  • Research Site

    Osaka,
    Japan

    Site Not Available

  • Research Site

    Osaka 1853909,
    Japan

    Site Not Available

  • Research Site

    Saga,
    Japan

    Site Not Available

  • Research Site

    Saga 1853303,
    Japan

    Site Not Available

  • Research Site

    Saitama,
    Japan

    Site Not Available

  • Research Site

    Saitama 6940394,
    Japan

    Site Not Available

  • Research Site

    Shiga,
    Japan

    Site Not Available

  • Research Site

    Shiga 9115498,
    Japan

    Site Not Available

  • Research Site

    Shimane,
    Japan

    Site Not Available

  • Research Site

    Shimane 10987750,
    Japan

    Site Not Available

  • Research Site

    Shizuoka,
    Japan

    Site Not Available

  • Research Site

    Shizuoka 1851717,
    Japan

    Site Not Available

  • Research Site

    Tochigi,
    Japan

    Site Not Available

  • Research Site

    Tochigi 1850311,
    Japan

    Site Not Available

  • Research Site

    Tokushima,
    Japan

    Site Not Available

  • Research Site

    Tokushima 1850158,
    Japan

    Site Not Available

  • Research Site

    Tokyo,
    Japan

    Site Not Available

  • Research Site

    Tokyo 1850147,
    Japan

    Site Not Available

  • Research Site

    Tottori,
    Japan

    Site Not Available

  • Research Site

    Tottori 1849893,
    Japan

    Site Not Available

  • Research Site

    Toyama,
    Japan

    Site Not Available

  • Research Site

    Toyama 1849876,
    Japan

    Site Not Available

  • Research Site

    Wakayama,
    Japan

    Site Not Available

  • Research Site

    Wakayama 1926004,
    Japan

    Site Not Available

  • Research Site

    Yamagata,
    Japan

    Site Not Available

  • Research Site

    Yamagata 2110556,
    Japan

    Site Not Available

  • Research Site

    Yamaguchi,
    Japan

    Site Not Available

  • Research Site

    Yamaguchi 1848689,
    Japan

    Site Not Available

  • Research Site

    Yamanashi,
    Japan

    Site Not Available

  • Research Site

    Yamanashi 11611479,
    Japan

    Site Not Available

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