Fasenra Pediatric Japan Post-Marketing Study(PMS)

FASENRA® Subcutaneous Injection 30 mg / 10mg Syringe Protocol of Specific Drug Use Result Study for Pediatric Patients

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 Overview

• Status: Recruiting
• Conditions: Bronchial Asthma

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 Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Japan
  • Aichi, Japan
    • Recruiting
    • Research Site
  • Chiba, Japan
    • Recruiting
    • Research Site
  • Hiroshima, Japan
    • Recruiting
    • Research Site
  • Hokkaido, Japan
    • Recruiting
    • Research Site
  • Hyōgo, Japan
    • Recruiting
    • Research Site
  • Ibaraki, Japan
    • Active, not recruiting
    • Research Site
  • Ibaraki, Japan
    • Recruiting
    • Research Site
  • Kumamoto, Japan
    • Not yet recruiting
    • Research Site
  • Mie, Japan
    • Recruiting
    • Research Site
  • Okayama, Japan
    • Recruiting
    • Research Site
  • Osaka, Japan
    • Active, not recruiting
    • Research Site
  • Osaka, Japan
    • Recruiting
    • Research Site
  • Saitama, Japan
    • Recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ADRs	The incidence of ADRs related to Fasenra Safety Specification, Serious infection and other	from baseline to 1year

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Shunsuke Hiroki, AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: May 20, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: D3250C00100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No