NCT00500656

Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE)

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 icatibant/λ tranexamic acid =1 versus H1: λ icatibant/λ 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, controlled,parallel group study of a 30 mg s.c. formulation of icatibant for the treatment of patients with moderate to very severe symptoms of cutaneous and/or 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.

Conditions

• Hereditary Angioedema

Interventions

Type	Name	Description
DRUG	Icatibant	Icatibant: a stable, synthetic decapeptide and specific BK B2 receptor antagonist.
DRUG	Tranexamic Acid	over encapsulated film tablet an anti-fibrinolytic agent,is used in some European countries for the treatment of acute oedema episodes and the continuous prophylaxis of HAE.
DRUG	Oral Placebo	hard capsule matched to tranexamic acid
DRUG	S.C. Placebo	solution for injection, matched to icatibant for injection

Timeline

• Start date: 2005-03-01
• Primary completion: 2006-07-25
• Completion: 2006-07-25
• First posted: 2007-07-13
• Last updated: 2021-06-09
• Results posted: 2014-06-09

Locations

1 site across 1 country: Italy