Phase 3
Completed N=85
Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE)
Source: ClinicalTrials.gov NCT00500656 ↗Enrolled (actual)
85
Serious AEs
12.2%
Results posted
Jun 2014
Primary outcomePrimary: Time to Onset of Symptom Relief. — 2.0; 12.0 Hours — p=< 0.001
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Onset of Symptom Relief. |
2.0; 12.0 | < 0.001 sig |
| SECONDARY Time to Almost Complete Symptom Relief |
10.0; 51.0 | < 0.001 sig |
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
Data sourced from ClinicalTrials.gov (NCT00500656). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.