Conditions: Angioedema
Keywords: Hereditary Angioedema C1 inhibitor deficiency HAE Icatibant Bradykinin antagonist acute attack subcutaneous
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 84
Healthy volunteers: no

Brief summary:
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).

Detailed description:
This Phase II/III study consisted of two parts: A controlled phase and An Open label extension(OLE) phase. The controlled phase describes the double blind part of the study and was intended to evaluate the efficacy of icatibant in decreasing the time to onset of symptom relief compared with placebo for the first treated cutaneous and/or abdominal attack in randomised patients. Patients experienced a laryngeal attack were not randomised, but treated with open label icatibant according to the controlled phase procedures and assessments. The outcome of this group was to be reported descriptively. After treatment of the first attack in the controlled phase, the patients were eligible to enter the OLE phase. In the OLE phase, patients who experienced angioedema attacks severe enough to warrant treatment were to be treated with s.c. icatibant as appropriate until the end of the study.The OLE phase became a modified open label extension where all 56 patients who had been randomised and the last randomised patient had concluded the double-blind phase. The modified open label extension period permitted treatment for 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 double blind phase was still ongoing.

Arms:
arm 1: Patients who were randomized to icatibant in the controlled phase after they had an eligible first in-study attack. arm 2: Patients who were randomized to placebo in the controlled phase after they had an eligible first in-study attack. arm 3: Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase. arm 4: 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 (they were not treated during the Controlled phase but treated with icatibant during the Open Label Extension Phase (OLE) )

Interventions: intervention 1: Icatibant intervention 2: Placebo
Intervention descriptions: intervention 1: 30 mg (3mL) subcutaneous icatibant injection in the abdominal region intervention 2: Solution for injection, matched to study drug Single dose: 3 mL

Protocol document: