Washington, District of Columbia 20007

  • Angioedema


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).


Inclusion Criteria: - 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. Exclusion Criteria: - 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 screening examination; - Serious concomitant illnesses that the physician considers to be a contraindication for participation in the trial; - Pregnancy and/or breast-feeding.



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Washington, District of Columbia 20007
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 26, 2020

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