Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE)
Status:
Completed
Trial end date:
2006-07-25
Target enrollment:
Participant gender:
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