Clinical trial · Interventional
Aprepitant Versus Hydroxyzine in Persistent Aquagenic Pruritus for Patients With Myeloproliferative Neoplasms
Aprepitant Versus Hydroxyzine in Association With Cytoreductive Treatments for Patients With Myeloproliferative Neoplasia Suffering From Persistent Aquagenic Pruritus.
NCT03808805CI-TRIAL-00098331APHYPAPcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aquagenic Pruritus | — | UNRESOLVED | — |
| Myeloproliferative Disorder | Myeloproliferative Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aprepitant 80 mg | Drug | — | UNRESOLVED |
| Hydroxyzine 25mg | Drug | — | UNRESOLVED |
| Placebo of Aprepitant | Drug | — | UNRESOLVED |
| Placebo of Hydroxyzine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- studied group
- description
- Aprepitant 80 mg daily - 14 days Plus placebo of Hydroxyzine - 14 days
- interventionNames
- Drug: Aprepitant 80 mg
- Drug: Placebo of Hydroxyzine
- type
- ACTIVE_COMPARATOR
- label
- comparative group
- description
- Hydroxyzine 25 mg/d - 14 days Plus placebo of Aprepitant - 14 days
- interventionNames
- Drug: Hydroxyzine 25mg
- Drug: Placebo of Aprepitant
Primary outcomes (1)
- measure
- Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale )
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDLe Gall-Ianotto C, Verdet R, Nowak E, Le Roux L, Gasse A, Fiedler A, Carlhant-Kowalski D, Marcorelles P, Misery L, Ianotto JC. Rationale and design of the multicentric, double-blind, double-placebo, randomized trial APrepitant versus HYdroxyzine in association with cytoreductive treatments for patients with myeloproliferative neoplasia suffering from Persistent Aquagenic Pruritus. Trial acronym: APHYPAP. Trials. 2021 Dec 19;22(1):938. doi: 10.1186/s13063-021-05864-8. PMID 34923994