TEZSPIRE (Tezepelumab) Asthma Japan Post-Marketing Study (PMS)

Last updated: February 27, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asthma

Treatment

N/A

Clinical Study ID

NCT05729711
D5180C00034
  • All Genders

Study Summary

The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of Tezspire.

  1. Development of related AEs

  2. Contributing factors possibly having an impact on the safety and effectiveness

  3. Development of unexpected related AEs

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The evaluable patients are those treated with Tezspire for the first time due to "Bronchial asthma (only the patients with severe or intractable bronchial asthmawhich could not be controlled with the existing therapy)

Exclusion

Exclusion Criteria:

None

Study Design

Total Participants: 400
Study Start date:
April 04, 2023
Estimated Completion Date:
November 16, 2029

Study Description

The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of Tezspire.

  1. Development of related AEs

  2. Contributing factors possibly having an impact on the safety and effectiveness

  3. Development of unexpected related AEs

This investigation will be conducted to support the application for re-examination specified in Article 14-4 of the Act on Securing Quality, Effectiveness and Safety of Products Including Pharmaceuticals and Medical Devices.

Connect with a study center

  • Research Site

    Aichi,
    Japan

    Active - Recruiting

  • Research Site

    Akita,
    Japan

    Site Not Available

  • Research Site

    Aomori,
    Japan

    Site Not Available

  • Research Site

    Chiba,
    Japan

    Active - Recruiting

  • Research Site

    Fukui,
    Japan

    Site Not Available

  • Research Site

    Fukuoka,
    Japan

    Site Not Available

  • Research Site

    Gifu,
    Japan

    Active - Recruiting

  • Research Site

    Gunma,
    Japan

    Site Not Available

  • Research Site

    Hiroshima,
    Japan

    Site Not Available

  • Research Site

    Hokkaido,
    Japan

    Site Not Available

  • Research Site

    Hyogo,
    Japan

    Active - Recruiting

  • Research Site

    Ibaraki,
    Japan

    Active - Recruiting

  • Research Site

    Ishikawa,
    Japan

    Site Not Available

  • Research Site

    Iwate,
    Japan

    Site Not Available

  • Research Site

    Kagawa,
    Japan

    Site Not Available

  • Research Site

    Kanagawa,
    Japan

    Site Not Available

  • Research Site

    Kumamoto,
    Japan

    Site Not Available

  • Research Site

    Kyoto,
    Japan

    Site Not Available

  • Research Site

    Mie,
    Japan

    Active - Recruiting

  • Research Site

    Miyagi,
    Japan

    Site Not Available

  • Research Site

    Nara,
    Japan

    Site Not Available

  • Research Site

    Oita,
    Japan

    Active - Recruiting

  • Research Site

    Okayama,
    Japan

    Active - Recruiting

  • Research Site

    Osaka,
    Japan

    Active - Recruiting

  • Research Site

    Saitama,
    Japan

    Active - Recruiting

  • Research Site

    Shimane,
    Japan

    Active - Recruiting

  • Research Site

    Shizuoka,
    Japan

    Site Not Available

  • Research Site

    Tochigi,
    Japan

    Site Not Available

  • Research Site

    Tokyo,
    Japan

    Site Not Available

  • Research Site

    Toyama,
    Japan

    Site Not Available

  • Research Site

    Wakayama,
    Japan

    Active - Recruiting

  • Research Site

    Yamagata,
    Japan

    Site Not Available

  • Research Site

    Yamaguchi,
    Japan

    Site Not Available

  • Research Site

    Yamanashi,
    Japan

    Site Not Available

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