Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema
Completed · Phase 3 · Has a placebo group
Conditions studied: Angioedema
In brief
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).
Key facts
- Study ID
- NCT00097695
- Run by
- Shire
- People needed
- 84
- Starts
- 2004-12-28
- Expected to finish
- 2006-07-17
- Last updated by the study team
- 2021-06-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Georgetown University Hospital, Lombardi Cancer Center — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.