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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.