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Fasenra Pediatric Japan Post-Marketing Study(PMS)

NCT ID: NCT06427876

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-16

Study Completion Date

2027-03-17

Brief Summary

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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

Detailed Description

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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

Conditions

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Bronchial Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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 Criteria

none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shunsuke Hiroki

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Aichi, , Japan

Site Status RECRUITING

Research Site

Chiba, , Japan

Site Status RECRUITING

Research Site

Hiroshima, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Hokkaido, , Japan

Site Status RECRUITING

Research Site

Hyōgo, , Japan

Site Status RECRUITING

Research Site

Ibaraki, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Mie, , Japan

Site Status RECRUITING

Research Site

Okayama, , Japan

Site Status RECRUITING

Research Site

Osaka, , Japan

Site Status ACTIVE_NOT_RECRUITING

Research Site

Osaka, , Japan

Site Status RECRUITING

Research Site

Saitama, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

Phone: 1-877-240-9479

Email: [email protected]

Other Identifiers

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D3250C00100

Identifier Type: -

Identifier Source: org_study_id