Pilot study on efficacy and safety of bilastine in preventing angioedema attacks in patients with recurrent angioedema of unkown etiology (idiopatic angioedema, rIAE)

Phase 1

Active, not recruiting

• Conditions: recurrent idiopathic angioedema; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-003002-91-IT
• Lead Sponsor: Menarini International Operation Luxembourg SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-12
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1.Subjects must have given a written informed consent;
2.Male or female;
3.Age = 18 years;
4.Diagnosis of recurrent IAE (according to Kaplan-Greaves 2005 criteria - Annex )
5.History of = 9 days of moderate to severe cutaneous or mucosal angioedema during the last 12 weeks;
6.C1-inhibitor functional levels = 60% of normal values;
7.Able to complete screening and assessments;
8.Women of childbearing potential must have a negative urine pregnancy test;
9.Willingness and ability to participate in the study;
10.No other experimental treatments;

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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.Diagnosis of angioedema of any defined cause: allergic, hereditary/acquired C1-Inhibitor deficiency, ACE (Angiotensin Converting Enzyme) inhibitor or NSAID induced angioedema, drug and/or food/disease induced angioedema (according to Kaplan-Greaves 2005 criteria);
2.Participation in a clinical trial of another Investigational Product (IP) within the past month;
3.Chronic use within the last 3 month before recruitment of systemic or topical corticosteroids, any other systemic antihistamine, anti-leukotrienes, sodium cromoglycate or nedocromil, tricyclic antidepressants, ACE-inibhitors, ARB (Angiotensin Receptor Blockers), tranexamic acid, with the exception of the case in which some of them have been used for the angioedema attacks.
4.Use of antihistamines or corticosteroids within the week prior to study randomization.
5.Evidence of clinically relevant or chronic disease or condition that upon the judgment of the investigator contraindicates participation to the study (eg history of autoimmune disorders, Hodgkin’s disease, cardiovascular, neurological, hepatic, renal or malignant diseases);
6.Pregnancy and/or breast-feeding;
7.Mental condition rendering the subject, in the opinion of the investigator, unable to understand the nature, scope and possible consequences of the study;
8.Unlikely to comply with the protocol, for example, uncooperative attitude, inability to return for follow-up visits, or unlikely to complete the study for any reason;
9.Known hypersensitivity to bilastine, its excipients, H1-antihistamines, benzimidazoles

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified