Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500656
Status:
COMPLETED
Last Update Posted:
2021-06-09
First Post:
2007-07-12
Brief Title:
Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema HAE
Sponsor:
Shire
Organization:
Takeda
Study Overview
Official Title:
Randomised Double Blind Controlled Parallel Group Multicentre Study of a Subcutaneous Formulation of Icatibant Versus Oral Tranexamic Acid for the Treatment of Hereditary Angioedema HAE
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:
FAST2
Brief Summary:
Primary Outcome Measures
The primary endpoint was the time to onset of symptom relief of the first attack in the double blind phase H0 λ icatibantλ tranexamic acid 1 versus H1 λ icatibantλ tranexamic acid 1 Where λ icatibant refers to the hazard rate under icatibant and λ tranexamic acid refers to the hazard rate under tranexamic acid
Secondary Outcome Measures
Additional efficacy assessments Time to Almost Complete Symptom Relief
Safety and tolerability
Pharmacoeconomics
The primary endpoint was the time to onset of symptom relief of the first attack in the double blind phase H0 λ icatibantλ tranexamic acid 1 versus H1 λ icatibantλ tranexamic acid 1 Where λ icatibant refers to the hazard rate under icatibant and λ tranexamic acid refers to the hazard rate under tranexamic acid
Secondary Outcome Measures
Additional efficacy assessments Time to Almost Complete Symptom Relief
Safety and tolerability
Pharmacoeconomics
Detailed Description:
This was a Phase III randomised double blind double dummy multicentre controlledparallel group study of a 30 mg sc formulation of icatibant for the treatment of patients with moderate to very severe symptoms of cutaneous andor abdominal symptoms of HAE
The study consisted of two parts controlled phase and OLE phase For the primary endpoint Efficacy was determined by evaluating the differences in study outcomes using a Visual Analogue Scale for patients treated with icatibant and tranexamic acid
The study consisted of two parts controlled phase and OLE phase For the primary endpoint Efficacy was determined by evaluating the differences in study outcomes using a Visual Analogue Scale for patients treated with icatibant and tranexamic acid
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 |
|---|---|---|---|
| 2004-001540-71 | EUDRACT_NUMBER | None | None |