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

NCT03808805 | Completed Phase 3 DMC

• 2 other identifiers: ApHyPAP 29BRC18.00362018-000426-66
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Myeloproliferative Disorder; Aquagenic Pruritus

Outcome Measures

Primary Outcomes (1)

• Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale )

  number of patients with a pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale wich measure the intensity of symptoms of pruritus, 0 is minimum and 10 is maximum intensity of symptoms)

  at 15 days

Secondary Outcomes (22)

• Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale )

  at 60 days

• Cessation of pruritus

  at 15 days

• Cessation of pruritus

  at 60 days

• Time observed to decreased the VAS to 3/10

  01 to 60 days

• Duration of treatment effectiveness

  1 to 60 days

Study Arms (2)

studied group

EXPERIMENTAL

Aprepitant 80 mg daily - 14 days Plus placebo of Hydroxyzine - 14 days

Drug: Aprepitant 80 mg; Drug: Placebo of Hydroxyzine

comparative group

ACTIVE COMPARATOR

Hydroxyzine 25 mg/d - 14 days Plus placebo of Aprepitant - 14 days

Drug: Hydroxyzine 25mg; Drug: Placebo of Aprepitant

Interventions

Aprepitant 80 mg DRUG

oral therapy - daily dose - 14 days

studied group

Hydroxyzine 25mg DRUG

oral therapy - daily dose - 14 days

comparative group

Placebo of Hydroxyzine DRUG

oral therapy - daily dose - 14 days

studied group

Placebo of Aprepitant DRUG

oral therapy - daily dose - 14 days

comparative group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (11)

CHRU de Brest - Hôpital Morvan

Brest, Brest Cedex, 29609, France

Location

Centre Hospitalier de Cornouaille

Quimper, Quimper, 29107, France

Location

CHU d'Angers

Angers, 49933, France

Location

CHU de Caen

Caen, 14033, France

Location

Centre Hospitalier de Douarnenez

Douarnenez, 29171, France

Location

CHU Grenoble Alpes

Grenoble, 38043, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Centre Hospitalier des Pays de Morlaix

Morlaix, 29672, France

Location

CHU de Nantes

Nantes, 44093, France

Location

Hôpital Pontchaillou

Rennes, France

Location

Hôpital Yves Le Foll

Saint-Brieuc, 22027, France

Location

Related Publications (1)

• Le 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 DERIVED

MeSH Terms

Conditions

Myeloproliferative Disorders

Interventions

Aprepitant; Hydroxyzine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Jean-Christophe IANOTTO, MD, PhD

  Hématologie Clinique-Institut de Cancéro-Hématologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase 3, randomized prospective study, double blind-double placebo

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: January 18, 2019
• Study Start: April 16, 2019
• Primary Completion: September 1, 2023
• Study Completion: August 22, 2024
• Last Updated: December 3, 2025

Record last verified: 2024-08

Locations

FR (11)