Fasenra Pediatric Japan Post-Marketing Study(PMS)

Status Not yet recruiting

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06427876
Study type	Observational
Source	AstraZeneca
Contact	AstraZeneca Clinical Study Information Center
Phone	1-877-240-9479
Email	information.center@astrazeneca.com
Status	Not yet recruiting
Phase
Start date	July 31, 2024
Completion date	March 17, 2027

View Details

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