Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema

• Status: Completed
• Trial end date: 2006-07-17
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Bradykinin; Icatibant

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.