drugset / Trial / NCT03789422

Tranexamic Acid and Spontaneous Chronic Urticaria

NCT03789422

Phase 4 Unknown 80 enrolled University Hospital, Grenoble
RandomizedCrossoverDouble-blindTreatment

Summary

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.

Timeline

Start
2019-12-10
Primary completion
2022-09
Completion
2022-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Levocetirizine Unknown 10 mg
Comparator Levocetirizine Unknown 20 mg
Comparator Tranexamic Acid Small molecule 2 g

Indications