Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292981
Status:
COMPLETED
Last Update Posted:
2015-05-07
First Post:
2006-02-15
Brief Title:
C1 Esterase Inhibitor in Hereditary Angioedema HAEExtension Study
Sponsor:
CSL Behring
Organization:
CSL Behring
Study Overview
Official Title:
Open-label Extension Study of CE1145 Human Pasteurized C1 Esterase Inhibitor Concentrate in Subjects With Congenital C1-INH Deficiency and Acute HAE Attacks
Status:
COMPLETED
Status Verified Date:
2011-10
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:
Hereditary angioedema HAE is a rare disorder characterized by congenital lack of functional C1 esterase inhibitor If not treated adequately the acute attacks of HAE can be life-threatening and may even result in fatalities especially in case of involvement of the larynxThe planned extension study is designed to enrol subjects that participated in the pivotal study in order to provide them with C1-INH for treatment of acute HAE attacks for 24 months or until the licensing procedure for C1-INH is finalized whatever comes first
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 |
|---|---|---|---|
| 1453 | OTHER | CSL Behring | None |