Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04648930
Status:
COMPLETED
Last Update Posted:
2023-08-23
First Post:
2020-11-24
Brief Title:
Special Drug Use Observational Study of Xolair in Patients With Severe to Most Severe Seasonal Allergic Rhinitis Aged 12 Years and 18 Years Whose Symptoms Were Inadequately Controlled Despite to Conventional Therapies
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Special Drug Use Observational Study of Xolair in Patients With Severe to Most Severe Seasonal Allergic Rhinitis Aged 12 Years and 18 Years Whose Symptoms Were Inadequately Controlled Despite to Conventional Therapies
Status:
COMPLETED
Status Verified Date:
2023-08
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:
This was a multicenter uncontrolled open-label special drug use study to investigate the safety and efficacy of Xolair by collecting data in its clinical setting in patients with severe to most severe seasonal allergic rhinitis aged 12 years and 18 years whose symptoms were inadequately controlled despite to conventional therapies and used Xolair
Detailed Description:
The observation period lasted for up to 24 weeks with Day 1 defined as the start date of Xolair treatment It should be noted that because the duration of Xolair treatment depends on the pollen dispersal situation and other factors patients who completed or discontinued Xolair treatment before the visit at 24 weeks after the start of treatment were followed up until the date of last dose of Xolair 30 days and the results were recorded in the CRF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None