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