Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00456508
Status:
COMPLETED
Last Update Posted:
2021-06-08
First Post:
2007-04-04
Brief Title:
Safety and Efficacy Study of Repeated Doses of DX-88 Ecallantide to Treat Attacks of Hereditary Angioedema HAE
Sponsor:
Shire
Organization:
Takeda
Study Overview
Official Title:
Open-label Patient Continuation of DX-88 Ecallantide for Acute Hereditary Angioedema Attacks
Status:
COMPLETED
Status Verified Date:
2021-05
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 study is to evaluate the efficacy and safety of repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE patients continued access to ecallantide In addition patients enrolled in DX-8820 EDEMA4 trial will be followed up and treated for subsequent attacks in this trial
Detailed Description:
This is an open label trial
The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide in the treatment of acute attacks of hereditary angioedema This study is designed to provide efficacy and safety data on repeated use of ecallantide These data are intended to support the marketing authorization of ecallantide in the treatment of acute attacks of hereditary angioedema Efficacy and safety of ecallantide will be evaluated in this study
The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide in the treatment of acute attacks of hereditary angioedema This study is designed to provide efficacy and safety data on repeated use of ecallantide These data are intended to support the marketing authorization of ecallantide in the treatment of acute attacks of hereditary angioedema Efficacy and safety of ecallantide will be evaluated in this study
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