Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271512
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-02-14
Brief Title:
A Study of Participants with Β-Thalassemia Treated with Betibeglogene Autotemcel
Sponsor:
bluebird bio
Organization:
bluebird bio
Study Overview
Official Title:
A Safety and Effectiveness Registry Study of Patients with Β-Thalassemia Treated with Betibeglogene Autotemcel the Glostar Registry
Status:
RECRUITING
Status Verified Date:
2024-09
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 main aim of this study is to collect real-world longitudinal data on participants with β-thalassemia treated with betibeglogene autotemcel beti-cel in the post marketing setting To assess the long-term safety including the risk of newly diagnosed malignancies after treatment with beti-cel and evaluate the long-term effectiveness of treatment with beti-cel
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None