Ignite Creation Date:
2024-05-06 @ 1:44 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04108962
Status:
WITHDRAWN
Last Update Posted:
2022-02-01
First Post:
2019-09-24
Brief Title:
Benralizumab in the Treatment of Patients With Severe Asthma With ABPA
Sponsor:
Baylor Research Institute
Organization:
Baylor Research Institute
Study Overview
Official Title:
Phase IV Single-Center Open-Label Study Evaluating the Effects of an Anti-IL5 Receptor Alpha Benralizumab Monoclonal Antibody in the Treatment of Severe Asthma in Patients With Allergic Bronchopulmonary Aspergillosis
Status:
WITHDRAWN
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficult to find eligible patients willing to participate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase IV open-label study will evaluate effects of Benralizumab in the treatment of severe asthma in patients with allergic bronchopulmonary aspergillosis
Detailed Description:
Subjects who have been identified to have severe asthma with ABPA will be consented and enrolled in the study to receive benralizumab injections administered every 4 weeks for the first 3 injections with an additional injection eight weeks to follow for a total of 16 weeks active treatment with a follow-uptermination visit eight weeks from the last injection The termination visit will occur week 24 for subjects who complete the study treatment Subjects who receive the first dose of benralizumab but withdraw from the study or terminate study treatment for any reason should complete all the procedures outlined for the termination visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None