Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE)

Access Programs

Disease Information

Descriptive Information
Brief Title † Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE)
Official Title † Randomised Double Blind, Controlled, Parallel Group, Multicentre Study of a Subcutaneous Formulation of Icatibant Versus Oral Tranexamic Acid for the Treatment of Hereditary Angioedema (HAE)
Brief Summary Primary Outcome Measures: The primary endpoint was the time to onset of symptom relief of the first attack in the double blind phase. H0: λ icatibant/λ tranexamic acid =1 versus H1: λ icatibant/λ tranexamic acid ≠1 Where: λ icatibant refers to the hazard rate under icatibant and λ tranexamic acid refers to the hazard rate under tranexamic acid. Secondary Outcome Measures: - Additional efficacy assessments (Time to Almost Complete Symptom Relief) - Safety and tolerability - Pharmacoeconomics
Detailed Description This was a Phase III, randomised, double blind, double dummy, multicentre, controlled,parallel group study of a 30 mg s.c. formulation of icatibant for the treatment of patients with moderate to very severe symptoms of cutaneous and/or abdominal symptoms of HAE. The study consisted of two parts: controlled phase and OLE phase. For the primary endpoint, Efficacy was determined by evaluating the differences in study outcomes using a Visual Analogue Scale for patients treated with icatibant and tranexamic acid.
Study Phase Phase 3
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary Outcome Measure † Time to Onset of Symptom Relief.
Secondary Outcome Measure † Time to Almost Complete Symptom Relief
Condition † Hereditary Angioedema
Intervention † DrugIcatibant
Study Arms / Comparison Groups Randomized controlled -Icatibant Subjects received S.C icatibant+ oral placebo Icatibant Form: solution for injection, 3 mL, 10 mg/mL Single dose: 30 mg (3 mL) Placebo Form: hard capsule Single dose: 2 capsules Frequency: 3 x 2 capsules for 2 days, taken orally, 6 to 8 hours apart Randomized controlled-Tranexamic acid Subjects received oral Tranexamic acid+ S.C. placebo Tranexamic acid Form: over encapsulated film tablet Single dose: 1000 mg (2 capsules) Frequency: 3 x 2 capsules for 2 days, taken orally, 6 to 8 hours apart Placebo Form: solution for injection, matched to icatibant for injection Single dose: 3 mL Frequency: one subcutaneous injection in the abdominal region Controlled Open-label / laryngeal attack Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase. Untreated patients at the baseline Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing were treated in the open label phase with icatibant
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 85
Start Date † March 2005
Completion Date March 2008
Primary Completion Date March 2008
Eligibility Criteria † Inclusion Criteria: - Age above 18 years; - Documented diagnosis of HAE Type I or II (confirmed C1-INH deficiency); - Current edema in the cutaneous, abdominal and/or laryngeal areas; - Current edema moderate to severe according to the investigator's Symptom Score. Exclusion Criteria: - Diagnosis of angioedema other than HAE, - 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 angioedema attack - Treatment with replacement therapy, including C1-INH products, less than 3 days before onset of the current angioedema attack - Treatment with Tranexamic acid replacement therapy within a week before onset of the current angioedema attack - Treatment with ACE inhibitors - Contraindications for Tranexamic acid - Evidence of coronary artery disease based on medical history or Screening examination in particular unstable angina pectoris or severe coronary heart disease - Congestive heart failure (class 3 and 4) - Serum creatinine level of ≥ 250 μmol/L - Serious concomitant illness that the investigator considered to be a contraindication for participation in the trial - Pregnancy (as assessed prior to treatment) and/or breast-feeding
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Italy
Administrative Information
NCT ID † NCT00500656
Organization ID JE049 #2102
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Shire
Collaborators ††
Investigators † Principal Investigator: Marco Cicardi, Prof. Dr., University of Milan
Information Provided By
Verification Date May 2014
First Received Date † July 12, 2007
Last Updated Date June 25, 2014
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
Find a Clinical Trial
Related Videos
by Abidemi Uruejoma
by Abidemi Uruejoma
by Abidemi Uruejoma
by Abidemi Uruejoma
by Abidemi Uruejoma
Free Newsletter