Conditions: Hereditary Angioedema
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 85
Healthy volunteers: no

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 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.

Arms:
arm 1: Subjects received S.C icatibant+ oral placebo

Icatibant Form: solution for injection, 3 mL, 10 mg/mL Single dose: 30 mg (3 mL)

Placebo Form: hard capsule Single dose: 2 capsules Frequency: 3 x 2 capsules for 2 days, taken orally, 6 to 8 hours apart arm 2: Subjects received oral Tranexamic acid+ S.C. placebo

Tranexamic acid Form: over encapsulated film tablet Single dose: 1000 mg (2 capsules) Frequency: 3 x 2 capsules for 2 days, taken orally, 6 to 8 hours apart

Placebo Form: solution for injection, matched to icatibant for injection Single dose: 3 mL Frequency: one subcutaneous injection in the abdominal region arm 3: Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase. arm 4: 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 controlled phase was ongoing were treated in the open label phase with icatibant

Interventions: intervention 1: Icatibant intervention 2: Tranexamic Acid intervention 3: Oral Placebo intervention 4: S.C. Placebo
Intervention descriptions: intervention 1: Icatibant: a stable, synthetic decapeptide and specific BK B2 receptor antagonist. intervention 2: 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. intervention 3: hard capsule matched to tranexamic acid intervention 4: solution for injection, matched to icatibant for injection

Protocol document: