Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00168103
Status:
COMPLETED
Last Update Posted:
2015-03-31
First Post:
2005-09-12
Brief Title:
Human C1 Esterase Inhibitor C1-INH in Subjects With Acute Abdominal or Facial Hereditary Angioedema HAE Attacks
Sponsor:
CSL Behring
Organization:
CSL Behring
Study Overview
Official Title:
Human Pasteurized C1 Esterase Inhibitor Concentrate CE1145 in Subjects With Congenital C1-INH Deficiency and Acute Abdominal or Facial HAE Attacks
Status:
COMPLETED
Status Verified Date:
2011-02
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:
HAE is a rare disorder characterized by functional C1 esterase inhibitor deficiency If not treated adequately the acute attacks of HAE can be life-threatening and may even result in fatalities especially in case of swelling of the larynx This clinical Phase 2Phase 3 study was designed to provide clinically relevant data on dosing efficacy and safety in subjects with HAE
Detailed Description:
For each subject only a single abdominal or facial attack was treated and evaluated After receiving treatment subjects were observed for a minimum of 4 hours after which they could be discharged from the study center if they reported onset of symptom relief Starting from 4 hours after treatment subjects who reported insufficient or no symptom relief could receive a second dose of double-blind treatment called rescue medication as follows C1-INH 20 Ukg bw for subjects initially receiving placebo C1-INH 10 Ukg bw for subjects initially receiving C1-INH 10 Ukg bw and placebo for subjects initially receiving C1-INH 20 Ukg bw
The study was defined to be successful if the primary outcome measure and at least one of the secondary outcome measures were met in the comparison between the C1-INH 20 Ukg bw group and the Placebo group
The study was defined to be successful if the primary outcome measure and at least one of the secondary outcome measures were met in the comparison between the C1-INH 20 Ukg bw group and the Placebo group
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 |
|---|---|---|---|
| 2004-001186-17 | EUDRACT_NUMBER | None | None |