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