Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00225147
Status:
COMPLETED
Last Update Posted:
2013-02-22
First Post:
2005-09-20
Brief Title:
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Sponsor:
Pharming Technologies BV
Organization:
Pharming Technologies BV
Study Overview
Official Title:
A Randomized Placebo-controlled Double Blind Phase IIIII Study of the Safety and Efficacy of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Status:
COMPLETED
Status Verified Date:
2013-02
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:
Hereditary angioedema HAE is a genetic disorder characterized by sudden recurrent attacks of local swelling angioedema These attacks are often painful and disabling and in some cases life-threatening HAE is caused by mutations in the C1INH gene that lead to a decrease in the blood level of functional C1INH This multi-center study was designed to assess the safety and tolerability efficacy and pharmacokineticspharmacodynamics of recombinant human C1 inhibitor rhC1INH in the treatment of acute hereditary angioedema attacks
Funding Source - FDA OOPD
Funding Source - FDA OOPD
Detailed Description:
A prospectively planned interim analysis will be performed on the double-blind data
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