Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 4
University Hospital, Grenoble (Voir sur ClinicalTrials)
décembre 2019
septembre 2022
29 juin 2024
Spontaneous chronic urticaria (UCS) is a disease that affects 1% of the general
population with a potentially severe impact on quality of life. Most patients respond
favorably to long-term antihistamine treatment, but sometimes it is necessary to give a
high dose (4 times the formal dose, Berlin consensus 2016). These high doses are often
accompanied by side effects requiring cessation of treatment. The therapeutic alternative
is then omalizumab, an expensive biotherapy. UCS is secondary to non-specific mast cell
activation. It has been shown to be associated with activation of fibrinolysis that
correlates with the severity of symptoms. Patients with UCS resistant to levocetirizine
were shown to have higher D-dimer levels than patients who responded to antihistamines.
Tranexamic acid is a molecule with antifibrinolytic propertiesSeveral cases of severe
chronic urticaria responding favorably to treatment with tranexamic acid have been
reported. In our department, Investigators also noticed the improvement of some of their
patients on tranexamic acid. The combination of these two treatments appears to be
synergistic: action on histamine receptors and control of fibrinolysis.
The investigators propose to evaluate the association of tranexamic acid and
levocetirizine for the treatment of chronic spontaneous urticaria.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Grenoble-Alpes - 38043 - Grenoble - France | Mélanie Arnaud | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patients with 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 the following symptoms : urticarial eruptions and
/ or recurrent angioedema for at least 6 weeks
- Patients with 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 the following symptoms : urticarial eruptions and
/ or recurrent angioedema for at least 6 weeks
- Urticaria associated with a specific systemic disease including cutaneous and
systemic mastocytosis, urticarial vasculitis, autoinflammatory diseases associated
with cryopyrin
- Bradykinin angioedema and isolated angioedema whose origin is not clearly
attributable to spontaneous chronic urticaria.
- Presence of a contraindication to tranexamic acid and to levocetirizine