Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261833
Status:
COMPLETED
Last Update Posted:
2015-01-19
First Post:
2005-12-02
Brief Title:
Zemaira in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor Deficiency
Sponsor:
CSL Behring
Organization:
CSL Behring
Study Overview
Official Title:
A Randomized Placebo-Controlled Double-Blind Multicenter Phase IIIIV Study to Compare the Efficacy and Safety of 60mgkg Body Weight of Zemaira Weekly IV Administration With Placebo Weekly IV Administration in Chronic Augmentation and Maintenance Therapy in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor Deficiency
Status:
COMPLETED
Status Verified Date:
2015-01
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 randomized placebo-controlled double-blind multicenter phase IIIIV study to compare the efficacy and safety of Zemaira with placebo in subjects with emphysema due to alpha1-proteinase inhibitor deficiency The effect of Zemaira on the progression of emphysema will be assessed by the decline of lung density measured by computed tomography CT
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1449 | OTHER | None | None |
| 2005-003459-12 | EUDRACT_NUMBER | CSL Behring | None |