Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161707
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2005-09-08
Brief Title:
Safety Study of an Aerosolized Recombinant Alpha 1-Antitrypsin in Subjects With Alpha 1-Antitrypsin Deficiency
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
Phase I Safety Investigation of an Aerosolized Recombinant Alpha 1-Antitrypsin 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 purpose of this randomized double-blind placebo-controlled study is to evaluate the short-term safety of inhaled recombinant alpha 1-antitrypsin rAAT in subjects with alpha 1-antitrypsin deficiency The subjects are randomized to receive placebo or one of 4 doses of rAAT The 4 doses are tested in a consecutive manner from lowest to highest
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