Idiopathic angioedema. MedDRA version: 9.1 Level: LLT Classification code 10051379
Conditions
Interventions
Trade Name: FIRAZYR
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ICATIBANT
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pha
Sponsors
AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Male or female; ? Age > or = 18 years; ? Recurrent attacks (≥ 6 per year) of idiopathic non-histaminergic angioedema lasting since a minimum of 3 months; ? C1-inhibitor functional levels ≥ 50% of normal values ? Recurrence of angioedema attacks during antihistamine prophylaxis ? Current edema attack must be in the cutaneous or mucosal areas; ? Current edema attack must be moderate to severe; ? Able to complete screening and baseline assessments, and commence treatment within 6 hours of the time the current attack becomes moderate; ? Women of childbearing potential must have a negative urine pregnancy test; ? Signed written Informed Consent given. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Diagnosis of angioedema of any defined cause, for example, allergic, hereditary/acquired C1-Inhibitor deficiency, ACE inhibitor induced angioedema, drug and/or food induced angioedema; ? Previous diagnosis of chronic urticaria ? Participation in a clinical trial of another Investigational Product (IP) within the past month; ? Treatment with any medication except ongoing treatment since onset of the current edema attack; ? Treatment with glucocorticoids and antihistamines in the previous 7 days since onset of the current edema attack; ? On treatment with ACE inhibitors or ARB; ? Evidence of severe coronary artery disease based on medical history or screening examination; ? Pregnancy and/or breast-feeding; ? Mental condition rendering the subject, in the opinion of the investigator, unable to understand the nature, scope and possible consequences of the study; ? Unlikely to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the efficacy of the bradykinin (BK) antagonist Icatibant, compared with gold standard (GS) therapy, in the relief of symptoms resulting from moderate to severe angioedema of the face, neck, arms, genitals, tongue, pharinx and larynx.;Secondary Objective: None.;Primary end point(s): The primary efficacy endpoint is the time to onset of symptom relief. The severity of the symptoms will be measured using a Visual Analogue Scale (VAS) of 100 mm length. The first absolute reduction by 20% of pretreatment value, confirmed at three consecutive measurements after treatment, is defined as the onset of symptom relief. The difference in time to onset of symptom relief is tested using the VAS with highest score at baseline, if baseline value are identical hierarchical value will be as follow: dyspnea>dysphagia>swelling. | — |
Countries
Italy
Outcome results
None listed