Tranexamic Acid and Spontaneous Chronic Urticaria

NCT03789422 | Unknown Phase 4 DMC

• 1 other identifier: TACUS- 38RC18.103
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Spontaneous Urticaria

Outcome Measures

Primary Outcomes (2)

• 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

• Tolerance of the association tranexamic acid and levocetirizine

  Number of adverse events

  28 days

Secondary Outcomes (2)

• 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)

  28 days

• Clinical characteristics of responders

  28 days

Study Arms (2)

Association drugs

ACTIVE COMPARATOR

levocetirizine 10mg/day + tranexamic acid (AT) 2g/day for a month

Drug: association of levocetirizine and tranexamic acid

one drug

ACTIVE COMPARATOR

Levocetirizine 20 mg/day for a month

Drug: Levocetirizine only

Interventions

association of levocetirizine and tranexamic acid DRUG

levocetirizine 10 mg/day + tranexamic acid 2 g/day

Association drugs

Levocetirizine only DRUG

levocetirizine 20 mg/day

one drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble-Alpes

Grenoble, 38043, France

RECRUITING

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Laurence BOUILLET, PhD

  Internal Medicine - University Hospital Grenoble-Alpes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raouf ZOUGLECH, MDS

CONTACT

4 76 76 78 38; rzouglech@chu-grenoble.fr

Tiphaine Montagnon

CONTACT

4 76 76 68 14; tmontagnon@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentric controlled randomized crossover study, double-blind

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: December 28, 2018
• Study Start: December 10, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

FR (1)