Fasenra Pediatric Japan Post-Marketing Study(PMS)

Recruiting

• Conditions: Bronchial Asthma

• Registration Number: NCT06427876
• Lead Sponsor: AstraZeneca

Brief 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

Detailed 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

Study Timeline

• Study First Submitted: 2024-05-20
• Study First Submitted QC: 2024-05-20
• Study First Posted: 2024-05-24
• Study Start: 2024-07-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2027-03-17
• Study Completion: 2027-03-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of ADRs	from baseline to 1year	The incidence of ADRs related to Fasenra Safety Specification, Serious infection and other

Trial Locations

Locations (1)

Research Site; 🇯🇵 Saitama, Japan