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NCT06427876 Clinical Trial

Fasenra Pediatric Japan Post-Marketing Study(PMS)

Bronchial Asthma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06427876
Other study ID # D3250C00100
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 31, 2024
Est. completion date March 17, 2027

Study information
Verified date May 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date March 17, 2027
Est. primary completion date March 17, 2027
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

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