IcatibaNt In Treatment of Idiopathic Angio Edema. - INITIAtE

Conditions: Idiopathic angioedema.
MedDRA version: 9.1Level: LLTClassification code 10051379

Registration Number: EUCTR2010-019037-10-IT

Lead Sponsor: AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

?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.