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Clinical Trials/EUCTR2018-003139-31-FR
EUCTR2018-003139-31-FRActive, not recruitingPhase 1

Efficacy and safety of levocetirizine alone or in combination with tranexamic acid in the treatment of spontaneous chronic urticaria. Multicentric controlled randomized study in cross-over, double-blind. - TACUS

CHU GRENOBLE ALPES0 sites80 target enrollmentStarted: October 3, 2018Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
80
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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

Investigators

Sponsor
CHU GRENOBLE ALPES

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