Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396006
Status:
COMPLETED
Last Update Posted:
2021-05-13
First Post:
2006-11-03
Brief Title:
Efficacy and Safety Study of Augmentation Therapy With ARALAST Fraction IV-1 Human Alpha 1 - Proteinase Inhibitor
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
The Effect of Augmentation Therapy With ARALAST Fraction IV-1 ARALAST Alpha1-Proteinase Inhibitor α1-PI on the Level of α1-PI and Other Analytes in the Bronchoalveolar BAL Epithelial Lining Fluid ELF
Status:
COMPLETED
Status Verified Date:
2021-04
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:
The purpose of this study is to evaluate the effects of weekly augmentation therapy with ARALAST Fraction IV-1 Fr IV-1 on epithelial lining fluid ELF alpha 1-proteinase inhibitor levels and other ELF analytes and to assess the safety of the treatment Eligible subjects with a diagnosis of severe congenital alpha 1-antitrypsin deficiency will receive 8 consecutive weekly treatments with 60 mgkgweek of functional ARALAST Fr IV-1 administered intravenously The efficacy and safety assessments will include two bronchoscopies with bronchoalveolar lavage on study initiation and on study termination and multiple imaging and laboratory safety assessments Each subject will participate for a minimum of 12 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
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