Chronique Spontaneous urticaria
Conditions
Interventions
Trade Name: EXACYL
Product Name: Tranexamic Acid
Pharmaceutical Form: Capsule
INN or Proposed INN: tranexamic acid
Other descriptive name: TRANEXAMIC ACID
Concentration unit: mg milligram(s)
Concentra
Sponsors
CHU GRENOBLE ALPES
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 1. Evolution of the UAS7 score between the beginning (J0) and the end (J28) of the treatment period. The analysis will be conducted per protocol and intention to treat and non-inferiority will be retained if both analyzes are convergent (Le Henanff, A. et al., JAMA 2006; 295: 1147-1151). Then, a hierarchical analysis on the intention-to-treat population will be carried out with a superiority test only if non-inferiority is retained in per protocol analysis. 2. Collection of adverse effects 3. Evolution of the UAS7 score between the beginning (D0) and the end (D28) of the treatment period 1. Evolution of the UAS7 score between the beginning (J0) and the end (J28) of the treatment period. The analysis will be conducted per protocol and intention to treat and non-inferiority will be retained if both analyzes are convergent (Le Henanff, A. et al., JAMA 2006; 295: 1147-1151). Then, a hierarchical analysis on the intention-to-treat population will be carried out with a superiority test only if non-inferiority is retained in per protocol analysis. 2. Collection of adverse effects 3. Evolution of the UAS7 score between the beginning (D0) and the end (D28) of the treatment period 1. Evolution of the UAS7 score between the beginning (J0) and the end (J28) of the treatment period. The analysis will be conducted per protocol and intention to treat and non-inferiority will be retained if both analyzes are convergent (Le Henanff, A. et al., JAMA 2006; 295: 1147-1151). Then, a hierarchical analysis on the intention-to-treat population will be carried out with a superiority test only if non-inferiority is retained in per protocol analysis. 2. Collection of adverse effects 3. Evolution of the UAS7 score between the beginning (D0) and the end (D28) of the treatment period 1. Evolution of the UAS7 score between the beginning (J0) and the end (J28) of the treatment period. The analysis will be convergent (Henanff, A. et al., JAMA 2006; 295: 1147-1151). Then, a | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Evolution of the AAS score between the beginning (J0) and the end (J28) of the treatment period. 2. Combined improvement criterion of at least 50% of the UAS7 clinical score and the AAS score. These are 2 activity scores validated by the latest EAACI consensus: - UAS7 score: score assessing pruritus and number of urticaria plaques - AAS score: score evaluating the activity of seizures 3. Differences in the clinical profiles of the responders to each of the therapies. 4. Area under the ROC curve and D-dimer calibration for the prediction of therapeutic response to tranexamic acid. 5. Improvement of the quality of life, evaluated by the 2 scores validated during the last international consensus: - CU-Q2oL score: assessing the impact of urticaria attacks - AE-QoL score: assessing the impact of episodes of angioedema associated with chronic urticaria 1.Evolution of the AAS score between the beginning (J0) and the end (J28) of the treatment period. 2. Combined improvement criterion of at least 50% of the UAS7 clinical score and the AAS score. These are 2 activity scores validated by the latest EAACI consensus: - UAS7 score: score assessing pruritus and number of urticaria plaques - AAS score: score evaluating the activity of seizures 3. Differences in the clinical profiles of the responders to each of the therapies. 4. Area under the ROC curve and D-dimer calibration for the prediction of therapeutic response to tranexamic acid. 5. Improvement of the quality of life, evaluated by the 2 scores validated during the last international consensus: - CU-Q2oL score: assessing the impact of urticaria attacks - AE-QoL score: assessing the impact of episodes of angioedema associated with chronic urticaria ;Timepoint(s) of evaluation of this end point: 9 weeks | — |
Countries
France
Contacts
Public ContactTiphaine Montagnon
CHU Grenoble-Alpes
Outcome results
None listed