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Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema

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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

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Dates

Posted On: 1 January, 2013
Modified On: 16 September, 2014

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