IcatibaNt In Treatment of Idiopathic Angio Edema. - INITIAtE

AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)0 个研究点开始时间: 2010年12月27日最近更新: 2014年2月3日

试验速览

暂无简介。

•?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

•?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.

发起方

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