Efficacy and safety of levocetirizine alone or in combination with tranexamic acid in the treatment of spontaneous chronic urticaria.

Phase 1

• Conditions: Chronique Spontaneous urticaria; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-003139-31-FR
• Lead Sponsor: CHU GRENOBLE ALPES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-03
• Last Update Posted: 10 December 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

- Patient over 18 years old
- having spontaneous chronic urticaria, according to the criteria of the European Academy of Allergology and Clinical Immunology (EAACI) in agreement with the European Dermatology Forum (EDF), and the World Allergy Organization (WAO), corresponding to an association of symptoms urticarial eruptions and / or recurrent angioedema for at least 6 weeks.
- having given his written consent
- affiliated to a social security scheme or beneficiary of such a scheme
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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

- Urticaria associated with a specific systemic disease including cutaneous and systemic mastocytosis, urticarial vasculitis, autoinflammatory diseases associated with cryopyrin
- Bradykinetic angioedema and isolated angioedema whose origin is not clearly attributable to spontaneous chronic urticaria.
- Presence of a contraindication to tranexamic acid: history of venous thromboembolic accident (deep vein thrombosis, pulmonary embolism) or arterial thromboembolic stroke (angina, myocardial infarction, stroke); fibrinolytic states reactive to consumption coagulopathy; severe renal failure; antecedent of convulsions.
- Presence of a contraindication to levocetirizine: known hypersensitivity to any of the components of the product, or to piperazine derivatives; severe renal insufficiency with creatinine clearance less than 10 ml / min. History of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency (presence of lactose in the tablet).
- Subject treated or having been treated with oral corticosteroids in the month preceding the selection
- Topic treated or treated by Montelukast in the week before the selection
- Subject treated or having been treated with H2 blockers in the week preceding the selection
- Subject receiving anticoagulant or antiaggregant.
- Subject treated or having been treated with immunosuppressants (eg methotrexate, ciclosporin, azathioprine, mycophenolate mofetil ...) in the month preceding the selection
- Persons referred to in Articles L1121-5 to L1121-8 of the CSP (pregnant woman, parturient, mother who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a measure of legal protection, can not to be included in clinical trials)
- Subject in exclusion period of another study
- Subject can not be contacted in case of emergency

Study & Design

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