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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional



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 Angi

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