Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE) (FAST2)
Hereditary Angioedema
About this trial
This is an interventional treatment trial for Hereditary Angioedema
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
Sites / Locations
- Università degli Studi di Milano, Dipartimento di Medicina Interna
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Experimental
Randomized controlled -Icatibant
Randomized controlled-Tranexamic acid
Controlled Open-label / laryngeal attack
Untreated patients at the baseline
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
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
Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
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