Study if Icatibant in Idioptahic Angioedema
- Conditions
- Idiopathic AngioedemaTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2011-002339-24-GB
- Lead Sponsor
- Barts and the London NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 9
• Male or female; • Age = than 18 years; • C1-inhibitor functional levels = 50% of normal values • Current oedema attack must be in the cutaneous or mucosal areas; • Current oedema attack must be moderate to severe; • 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
• 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; • Urticaria-associated angioedema • Participation in a clinical trial of another Investigational Product (IP) within the past month; • Treatment with any other medication likely to influence the outcome since onset of the current oedema attack; • On treatment with ACE inhibitors; • Evidence of severe coronary artery disease based on medical history or screening examination; • Pregnancy and/or breast-feeding; • Mental or physical 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method