Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema
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).
Official Title
Randomised, Double Blind, Placebo-Controlled, Multicenter Study of a Subcutaneous Formulation of Icatibant for the Treatment of Hereditary Angioedema
Conditions
- Angioedema
Study Type
Interventional
Study Design
Treatment, Randomised, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Further Details
Primary Outcome Measures:
- Symptom relief (patient)
Secondary Outcome Measures:
- Safety and tolerability
- Additional efficacy assessments
- Pharmacoeconomics
Study Start
August 2004
Eligibility & Criteria
Eligibility
- Ages Eligible for Study: 18 years and older
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
- Age above 18 years
- Documented diagnosis of HAE Type I or II (confirmed C1-INH deficiency)
- Current oedema be in the cutaneous, abdominal and/or laryngeal areas
- Current oedema 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 oedema attack
- Treatment with replacement therapy, including C1-INH products, less than 3 days from onset of the current oedema attack
- Treatment with ACE inhibitors
- 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 breastfeeding
Total Enrolment
56
Contact Details
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097695
Telephone: +1-202-444-2000
Locations
Georgetown University Hospital, Lombardi Cancer Center
Washington, District of Columbia
United States, 20007-2197
Sponsors and Collaborators
Jerini AG
Dates
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