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Tranexamic Acid and Spontaneous Chronic Urticaria (TACUS)

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ClinicalTrials.gov Identifier: NCT03789422
Recruitment Status : Not yet recruiting
First Posted : December 28, 2018
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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.


Condition or disease Intervention/treatment Phase
Chronic Spontaneous Urticaria Drug: association of levocetirizine and tranexamic acid Drug: Levocetirizine only Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Multicentric controlled randomized crossover study, double-blind
Masking: Double (Participant, Investigator)
Masking Description: Double blind
Primary Purpose: Treatment
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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives

Arm Intervention/treatment
Active Comparator: Association drugs
levocetirizine 10mg/day + tranexamic acid (AT) 2g/day for a month
Drug: association of levocetirizine and tranexamic acid
levocetirizine 10 mg/day + tranexamic acid 2 g/day

Active Comparator: one drug
Levocetirizine 20 mg/day for a month
Drug: Levocetirizine only
levocetirizine 20 mg/day




Primary Outcome Measures :
  1. Evolution of the Urticaria Activity Score 7 (UAS7) [ Time Frame: 28 days ]
    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.

  2. Tolerance of the association tranexamic acid and levocetirizine [ Time Frame: 28 days ]
    Number of adverse events


Secondary Outcome Measures :
  1. 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) [ Time Frame: 28 days ]
    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).

  2. Clinical characteristics of responders [ Time Frame: 28 days ]
    Identify the clinical characteristics of responders to the combination rather than antihistamines alone.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789422


Contacts
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Contact: Raouf ZOUGLECH, MDS 4 76 76 78 38 ext 0033 rzouglech@chu-grenoble.fr
Contact: Tiphaine Montagnon 4 76 76 68 14 ext 0033 tmontagnon@chu-grenoble.fr

Locations
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France
CHU Grenoble-Alpes Not yet recruiting
Grenoble, France, 38043
Contact: Raouf ZOUGLECH, MDS    4 76 76 78 38 ext 0033    rzouglech@chu-grenoble.fr   
Principal Investigator: Laurence BOUILLET, PhD         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Laurence BOUILLET, PhD Internal Medicine - University Hospital Grenoble-Alpes

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03789422     History of Changes
Other Study ID Numbers: TACUS- 38RC18.103
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tranexamic Acid
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cetirizine
Levocetirizine
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Allergic Agents