Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (NCT00097695) | Clinical Trial Compass
CompletedPhase 3
Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema
United States84 participantsStarted 2004-12-28
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age above 18 years;
* Documented diagnosis of HAE Type I or II (confirmed complement 1 esterase inhibitor \[C1-INH\] 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 (e.g. human C1-INH preparations), less than 3 days from onset of the current edema attack;
* Treatment with ACE inhibitors (e.g. Lotensin, Prinivil, Accupril);
* 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.