Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00157092
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2005-09-08
Brief Title:
Study of the Effect of Aerosolized Recombinant Alpha 1-Antitrypsin on Epithelial Lining Fluid Analytes in Subjects With Alpha 1-Antitrypsin Deficiency
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
A Phase 1B2A Study to Evaluate the Effect of Aerosolized Recombinant Alpha 1-Antitrypsin on Epithelial Lining Fluid Analytes in Subjects With Alpha 1-Antitrypsin Deficiency
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 study was a Phase 1B2A uncontrolled open-label single-center study in individuals with congenital AAT alpha 1-antitrypsin deficiency A baseline bronchoscopy with bronchoalveolar lavage BAL was performed 3 to a maximum of 4 weeks prior to the first administration of study drug Fifteen eligible subjects were randomized to receive 1 of 3 dosing regimens of rAAT 100 mg daily 100 mg twice daily or 200 mg daily administered via nebulization for 7 consecutive days A post-treatment nadir BAL was obtained on study Day 8 12 hours after last dose for subjects who receive drug therapy twice daily and 24 hours after the last dose for subjects who receive study product daily BALs were conducted in the same lung lobesegment Follow-up visits took place on Day 15 and Day 36
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