Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema
Angioedema
About this trial
This is an interventional treatment trial for Angioedema focused on measuring Hereditary Angioedema, C1 inhibitor deficiency, HAE, Icatibant, Bradykinin antagonist, acute attack, subcutaneous
Eligibility Criteria
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.
Sites / Locations
- Georgetown University Hospital, Lombardi Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Experimental
Icatibant- Randomized
Placebo-Randomized
Controlled Open-label / laryngeal attack
Untreated Patients at the baseline
Patients who were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
Patients who were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing (they were not treated during the Controlled phase but treated with icatibant during the Open Label Extension Phase (OLE) )