Informations générales (source: ClinicalTrials.gov)
Aprepitant Versus Hydroxyzine in Association With Cytoreductive Treatments for Patients With Myeloproliferative Neoplasia Suffering From Persistent Aquagenic Pruritus. (APHYPAP)
Interventional
Phase 3
University Hospital, Brest (Voir sur ClinicalTrials)
avril 2019
janvier 2022
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Hospitalier de Cornouaille - 29107 - Quimper - France | Pascal HUTIN, Dr | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Douarnenez - 29171 - Douarnenez - France | Anne-Sophie LE BRIS-MICHEL, Dr | Contact (sur clinicalTrials) | |||
| CHRU de Brest - Hôpital Morvan - 29609 - Brest - Brest Cedex - France | Jean-Christophe IANOTTO, Pr | Contact (sur clinicalTrials) | |||
| CHU d'Angers - 49933 - Angers - France | Françoise BOYER, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Yves Le Foll - 22027 - Saint-Brieuc - France | Iuliana MARTINIUC | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier des Pays de Morlaix - 29672 - Morlaix - France | Mohamed MALOU, Pr | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - 69373 - Lyon - France | Franck NICOLINI, Dr | Contact (sur clinicalTrials) | |||
| CHU de Caen - 14033 - Caen - France | Gandhi Laurent DAMAJ, Pr | Contact (sur clinicalTrials) | |||
| CHU de Nantes - 44093 - Nantes - France | Viviane DUBRUILLE, Dr | Contact (sur clinicalTrials) | |||
| CHU Grenoble Alpes - 38043 - Grenoble - France | Frédéric GARBAN, Pr | Contact (sur clinicalTrials) | |||
| Hôpital Pontchaillou - Rennes - France | Marc BERNARD, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Major patients with myeloproliferative neoplasms (polycythemia vera, essential
thrombocythaemia 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
- Major patients with myeloproliferative neoplasms (polycythemia vera, essential
thrombocythaemia 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
- patients with a physical or psychological disability to sign the consent form
- patients with myeloproliferative neoplasms and suffering of aquagenic pruritus but
only 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