Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262080
Status:
COMPLETED
Last Update Posted:
2021-06-11
First Post:
2005-12-05
Brief Title:
Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema HAE
Sponsor:
Shire
Organization:
Takeda
Study Overview
Official Title:
A Double-blind Placebo-controlled Study 72 Patients Randomized 11 Followed by a Repeat-dosing Phase to Assess the Efficacy and Safety of DX-88 Ecallantide Recombinant Plasma Kallikrein Inhibitor for the Treatment of Acute Attacks of Hereditary Angioedema
Status:
COMPLETED
Status Verified Date:
2021-06
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 determine if a subcutaneous dose of DX-88 ecallantide an investigational product is safe and relieves symptoms of HAE in patients suffering from moderate to severe acute attacks of HAE
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