Fasenra Pediatric Japan Post-Marketing Study(PMS)

Last updated: March 3, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

Allergies & Asthma

Asthma

Treatment

N/A

Clinical Study ID

NCT06427876
D3250C00100
  • All Genders

Study Summary

The purpose of the investigation is to confirm the followings under the post-marketing actual use of Fasenra® Subcutaneous Injection 30 mg / 10mg Syringe (hereinafter referred to as Fasenra).

  1. Development of unexpected related AEs*

  2. To grasp development of related AEs* in the real-world post-marketing setting.

  3. Effectiveness (pulmonary function and asthma control) * AEs investigator or MAH considers that there is a reasonable possibility that the experience may have been caused by the drug

Eligibility Criteria

Inclusion

Inclusion Criteria:

The evaluable patients in children aged ≥6 years to <15 years are those treated with Fasenra for the first time due to "Bronchial asthma (only the patients with intractable bronchial asthma which could not be controlled with the existing therapy)

Exclusion

Exclusion Criteria:

none

Study Design

Total Participants: 40
Study Start date:
July 16, 2024
Estimated Completion Date:
March 17, 2027

Study Description

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.

The purpose of the investigation is to confirm the followings under the post-marketing actual use of Fasenra® Subcutaneous Injection 30 mg / 10mg Syringe (hereinafter referred to as Fasenra).

  1. Development of unexpected related AEs*

  2. To grasp development of related AEs* in the real-world post-marketing setting.

  3. Effectiveness (pulmonary function and asthma control) * AEs investigator or MAH considers that there is a reasonable possibility that the experience may have been caused by the drug

Connect with a study center

  • Research Site

    Aichi,
    Japan

    Active - Recruiting

  • Research Site

    Aichi 11192139,
    Japan

    Site Not Available

  • Research Site

    Chiba,
    Japan

    Active - Recruiting

  • Research Site

    Chiba 2113015,
    Japan

    Site Not Available

  • Research Site

    Hiroshima,
    Japan

    Site Not Available

  • Research Site

    Hiroshima 1862415,
    Japan

    Site Not Available

  • Research Site

    Hokkaido,
    Japan

    Active - Recruiting

  • Research Site

    Hyogo,
    Japan

    Site Not Available

  • Research Site

    Hyōgo,
    Japan

    Active - Recruiting

  • 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

    Mie,
    Japan

    Active - Recruiting

  • Research Site

    Mie 1857357,
    Japan

    Site Not Available

  • Research Site

    Okayama,
    Japan

    Active - Recruiting

  • Research Site

    Okayama 1854383,
    Japan

    Site Not Available

  • Research Site

    Osaka,
    Japan

    Site Not Available

  • Research Site

    Osaka 1853909,
    Japan

    Site Not Available

  • Research Site

    Saitama,
    Japan

    Active - Recruiting

  • Research Site

    Saitama 6940394,
    Japan

    Site Not Available

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