Aprepitant Versus Hydroxyzine in Persistent Aquagenic Pruritus for Patients With Myeloproliferative Neoplasms

Last updated: November 26, 2025
Sponsor: University Hospital, Brest
Overall Status: Completed

Phase

3

Condition

Hives (Urticaria)

Rash

Thrombosis

Treatment

Aprepitant 80 mg

Placebo of Aprepitant

Hydroxyzine 25mg

Clinical Study ID

NCT03808805
ApHyPAP 29BRC18.0036
2018-000426-66
  • Ages > 18
  • All Genders

Study Summary

Phase 3, randomized prospective study, double blind-double placebo, testing oral therapies APREPITANT versus HYDROXYZINE in patients followed for myeloproliferative neoplasms and suffering of persistent aquagenic pruritus.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Major patients with myeloproliferative neoplasms (polycythemia vera, essentialthrombocythaemia or myelofibrosis)

  • and treated with hydroxyurea, pipobroman, anagrelide, α2a pegylated interferon,ruxolitinib or bled for more than 6 months

  • and suffering of persistent aquagenic pruritus

  • and with a pruritus intensity on Analogic Visual Scale >5/10

  • patients who gave their written consent for participation in the study

Exclusion

Exclusion Criteria:

  • patients with a physical or psychological disability to sign the consent form

  • patients with myeloproliferative neoplasms and suffering of aquagenic pruritus butonly treated by aspirin

  • patients already included in another therapeutic protocol

  • patients with diffuse dermatological disease where pruritus may be present (psoriasis, atopic dermatitis, prurigo

  • patients already on anti-anxiety and / or anti-depressant treatment

  • patients with absolute contraindications to the use of Aprepitant or Hydroxyzine

  • hypersensitivity to Aprepitant and / or Hydroxyzine or to any of their excipients

  • lactose intolerance

  • pregnant or lactating women

Study Design

Total Participants: 63
Treatment Group(s): 4
Primary Treatment: Aprepitant 80 mg
Phase: 3
Study Start date:
April 16, 2019
Estimated Completion Date:
August 22, 2024

Study Description

Identification of patients with myeloproliferative neoplasms and aquagenic pruritus. Evaluation of the intensity of the aquagenic pruritus. Patients with value >5/10 on the VAS (Visual Analogue Scale ) are proposed to participate to the protocole. Randomization between the two treatments. Duration of the treatment : 14 days. Regular evaluation of efficacity of the drugs (questionnaires). Evaluations will stop 2 months after the last intake. Blood samples will be collected before and after the intakes to study cytokine and neuropeptide levels.

Connect with a study center

  • CHRU de Brest - Hôpital Morvan

    Brest, Brest Cedex 29609
    France

    Site Not Available

  • CHRU de Brest - Hôpital Morvan

    Brest 3030300, Brest Cedex 29609
    France

    Site Not Available

  • Centre Hospitalier de Cornouaille

    Quimper 2984701, Quimper 29107
    France

    Site Not Available

  • CHU d'Angers

    Angers, 49933
    France

    Site Not Available

  • CHU d'Angers

    Angers 3037656, 49933
    France

    Site Not Available

  • CHU de Caen

    Caen, 14033
    France

    Site Not Available

  • CHU de Caen

    Caen 3029241, 14033
    France

    Site Not Available

  • Centre Hospitalier de Douarnenez

    Douarnenez, 29171
    France

    Site Not Available

  • Centre Hospitalier de Douarnenez

    Douarnenez 3020996, 29171
    France

    Site Not Available

  • CHU Grenoble Alpes

    Grenoble, 38043
    France

    Site Not Available

  • CHU Grenoble Alpes

    Grenoble 3014728, 38043
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon, 69373
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon 2996944, 69373
    France

    Site Not Available

  • Centre Hospitalier des Pays de Morlaix

    Morlaix, 29672
    France

    Site Not Available

  • Centre Hospitalier des Pays de Morlaix

    Morlaix 2991772, 29672
    France

    Site Not Available

  • CHU de Nantes

    Nantes, 44093
    France

    Site Not Available

  • CHU de Nantes

    Nantes 2990969, 44093
    France

    Site Not Available

  • Centre Hospitalier de Cornouaille

    Quimper, 29107
    France

    Site Not Available

  • Hôpital Pontchaillou

    Rennes,
    France

    Site Not Available

  • Hôpital Pontchaillou

    Rennes 2983990,
    France

    Site Not Available

  • Hôpital Yves Le Foll

    Saint-Brieuc, 22027
    France

    Site Not Available

  • Hôpital Yves Le Foll

    Saint-Brieuc 2981280, 22027
    France

    Site Not Available

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