Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427876
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-05-20
Brief Title:
Fasenra Pediatric Japan Post-Marketing StudyPMS
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
FASENRA Subcutaneous Injection 30 mg 10mg Syringe Protocol of Specific Drug Use Result Study for Pediatric Patients
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None