NCT06427876

Fasenra Pediatric Japan Post-Marketing Study(PMS)

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Bronchial Asthma

Timeline

• Start date: 2024-07-16
• Primary completion: 2027-03-17
• Completion: 2027-03-17
• First posted: 2024-05-24
• Last updated: 2026-03-04

Locations

11 sites across 1 country: Japan