Ignite Creation Date:
2024-05-06 @ 2:54 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02151526
Status:
COMPLETED
Last Update Posted:
2022-04-26
First Post:
2014-05-14
Brief Title:
A Study Evaluating the Safety and Efficacy of LentiGlobin BB305 Drug Product in β-Thalassemia Major Also Referred to as Transfusion-dependent β-Thalassemia TDT and Sickle Cell Disease
Sponsor:
bluebird bio
Organization:
bluebird bio
Study Overview
Official Title:
A Phase 12 Open Label Study Evaluating the Safety and Efficacy of Gene Therapy of the β-Hemoglobinopathies Sickle Cell Anemia and β-Thalassemia Major by Transplantation of Autologous CD34 Stem Cells Transduced Ex Vivo With a Lentiviral β-A-T87Q Globin Vector LentiGlobin BB305 Drug Product
Status:
COMPLETED
Status Verified Date:
2022-04
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 is a Phase 12 open label safety and efficacy study of the administration of LentiGlobin BB305 Drug Product to participants with either transfusion dependent beta-thalassemia TDT or sickle cell disease SCD
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-000695-42 | EUDRACT_NUMBER | None | None |