Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE) (NCT00500656) | Clinical Trial Compass
CompletedPhase 3
Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE)
Italy85 participantsStarted 2005-03-01
Plain-language 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
Who can participate
Age range18 Years
SexALL
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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