Tranexamic Acid and Spontaneous Chronic Urticaria

Chronic Spontaneous Urticaria Clinical Trial

— TACUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03789422
• Other study ID #: TACUS- 38RC18.103
• Status: Recruiting
• Phase: Phase 4
• Start date: December 10, 2019
• Est. completion date: September 2022

Study information

• Verified date: April 2021
• Source: University Hospital, Grenoble
• Contact: Raouf ZOUGLECH, MDS
• Phone: 4 76 76 78 38
• Email: rzouglech[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Multicentric controlled randomized crossover study, double-blind To evaluate the efficacy and safety of levocetirizine 10mg / day + tranexamic acid (AT) 2g / day versus levocetirizine 20mg / day alone in the chronic treatment of chronic urticaria evaluated at 4 weeks.

A hierarchical analysis will be implemented in the following order:

1. Non-inferiority of the combination levocetirizine 10 mg / day + tranexamic acid (TA) 2 g / day versus levocetirizine alone 20 mg / day in terms of effectiveness

2. Superiority of the combination levocetirizine 10 mg / day + tranexamic acid (AT) 2 g / day versus levocetirizine alone 20 mg / day in terms of tolerance

3. Superiority of levocetirizine 10mg / day + tranexamic acid (AT) 2g / day versus levocetirizine alone 20mg / day in terms of effectiveness Each objective will be tested sequentially if and only if the previous objective is validated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Spontaneous Urticaria
• Urticaria

Intervention

Drug:
• association of levocetirizine and tranexamic acid
levocetirizine 10 mg/day + tranexamic acid 2 g/day
• Levocetirizine only
levocetirizine 20 mg/day

Locations

Country	Name	City	State
France	CHU Grenoble-Alpes	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of the Urticaria Activity Score 7 (UAS7)	Evolution of the UAS7 score between the beginning (J0) and the end (J28) of the treatment period. To calculate the score, the patient rates the number of papules and itching intensity from 0 to 3 daily for 7 days. 0 corresponds to no papules and no itching, 3 corresponds to more than 50 papules per 24h and intense itching that can cause daily life. This makes a score of 0 to 6 per day accumulated over 7 days, ranging from 0 to 42.	28 days
Primary	Tolerance of the association tranexamic acid and levocetirizine	Number of adverse events	28 days
Secondary	To demonstrate the non-inferiority of levocetirizine 10mg / day + tranexamic acid (AT) 2g / day versus levocetirizine alone 20mg / day in terms of efficacy on the Angioedema Activity Score (AAS)	Evolution of the AAS score between the beginning (J0) and the end (J28) of the end of treatment. The AAS score is a The AAS consists of 5 questions as well as an opening question. A score between 0 and 3 is assigned to every answer field. The question scores are summed up to an AAS day sum score, 7 AAS day sum scores to an AAS week sum score (AAS7). Accordingly, the minimum and maximum possible AAS scores are 0-15 (AAS day sum score), 0-105 (AAS7).	28 days
Secondary	Clinical characteristics of responders	Identify the clinical characteristics of responders to the combination rather than antihistamines alone.	28 days