Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097695
Status:
COMPLETED
Last Update Posted:
2021-06-09
First Post:
2004-11-26
Brief Title:
Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema
Sponsor:
Shire
Organization:
Takeda
Study Overview
Official Title:
Randomized Double Blind Placebo-Controlled Multicenter Study of a Subcutaneous Formulation of Icatibant for the Treatment of Hereditary Angioedema
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 assess the efficacy and safety of Icatibant a bradykinin antagonist in the treatment of acute cutaneous andor abdominal attacks in patients with hereditary angioedema HAE
Detailed Description:
This Phase IIIII study consisted of two parts A controlled phase and An Open label extensionOLE phase The controlled phase describes the double blind part of the study and was intended to evaluate the efficacy of icatibant in decreasing the time to onset of symptom relief compared with placebo for the first treated cutaneous andor abdominal attack in randomised patients Patients experienced a laryngeal attack were not randomised but treated with open label icatibant according to the controlled phase procedures and assessments The outcome of this group was to be reported descriptively After treatment of the first attack in the controlled phase the patients were eligible to enter the OLE phase In the OLE phase patients who experienced angioedema attacks severe enough to warrant treatment were to be treated with sc icatibant as appropriate until the end of the studyThe OLE phase became a modified open label extension where all 56 patients who had been randomised and the last randomised patient had concluded the double-blind phase The modified open label extension period permitted treatment for patients who were screened and found eligible but did not experience an angioedema attack or had an attack that was not severe enough to merit treatment while the double blind phase was still ongoing
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 |
|---|---|---|---|
| FAST1 | OTHER | Shire HGT | None |