District of Columbia
The purpose of this study is to assess the efficacy and safety of Icatibant, a bradykinin
antagonist in the treatment of acute cutaneous and/or abdominal attacks in patients with
hereditary angioedema (HAE).
- Age above 18 years;
- Documented diagnosis of HAE Type I or II (confirmed C1-INH deficiency);
- Current edema be in the cutaneous, abdominal and/or laryngeal areas;
- Current edema be moderate to severe according to the investigator's Symptom Score.
- Diagnosis of angioedema other than HAE, for example, acquired angioedema (AAE);
- Participation in a clinical trial of another investigational medicinal product (IMP)
within the past month;
- Treatment with any pain medication since onset of the current edema attack;
- Treatment with replacement therapy, including C1-INH products, less than 3 days from
onset of the current edema attack;
- Treatment with ACE inhibitors;
- Evidence of severe, symptomatic coronary artery disease based on medical history or
- Serious concomitant illnesses that the physician considers to be a contraindication
for participation in the trial;
- Pregnancy and/or breast-feeding.