Myeloproliferative DisorderPhase 3APHYPAPNCT03808805
Aprepitant Versus Hydroxyzine in Persistent Aquagenic Pruritus for Patients With Myeloproliferative Neoplasms
A Phase 3 study testing Aprepitant 80 mg and Hydroxyzine 25mg in people with Myeloproliferative Disorder and Aquagenic Pruritus, run by University Hospital, Brest at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Disorder, Aquagenic Pruritus
- What is being tested?
- Aprepitant 80 mg and Hydroxyzine 25mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 11 sitesFrance
- Study dates
- 16 Apr 2019to 22 Aug 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- hypersensitivity to Aprepitant and / or Hydroxyzine or to any of their excipients
- lactose intolerance
- pregnant or lactating women
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CHU d'Angers
Angers, 49933
CHRU de Brest - Hôpital Morvan
Brest, Brest Cedex, 29609
CHU de Caen
Caen, 14033
Centre Hospitalier de Douarnenez
Douarnenez, 29171
CHU Grenoble Alpes
Grenoble, 38043
Centre Léon Bérard
Lyon, 69373
Centre Hospitalier des Pays de Morlaix
Morlaix, 29672
CHU de Nantes
Nantes, 44093
Centre Hospitalier de Cornouaille
Quimper, Quimper, 29107
Hôpital Pontchaillou
Rennes
Hôpital Yves Le Foll
Saint-Brieuc, 22027
About this study
Official title: Aprepitant Versus Hydroxyzine in Association With Cytoreductive Treatments for Patients With Myeloproliferative Neoplasia Suffering From Persistent Aquagenic Pruritus.
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.
Read the detailed 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.
- Conditions
- Myeloproliferative Disorder, Aquagenic Pruritus
- Being tested
- Aprepitant 80 mg, Hydroxyzine 25mg, Placebo of Hydroxyzine, Placebo of Aprepitant
- Medical subject headings
- Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aprepitant 80 mgDrug
oral therapy - daily dose - 14 days
Hydroxyzine 25mgDrug
oral therapy - daily dose - 14 days
Placebo of HydroxyzineDrug
oral therapy - daily dose - 14 days
Placebo of AprepitantDrug
oral therapy - daily dose - 14 days
| Study group | Role | What they receive |
|---|---|---|
| studied group | Experimental | Aprepitant 80 mg daily - 14 days Plus placebo of Hydroxyzine - 14 days Receives: Drug: Aprepitant 80 mg; Drug: Placebo of Hydroxyzine |
| comparative group | Active comparator | Hydroxyzine 25 mg/d - 14 days Plus placebo of Aprepitant - 14 days Receives: Drug: Hydroxyzine 25mg; Drug: Placebo of Aprepitant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at 15 days
Secondary outcomes (22)
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)
Measured: at 60 days
Cessation of pruritus
number of patients with a pruritus intensity at 0/10 on the VAS (Visual Analogue Scale wich measure the intensity of symptoms of pruritus, 0 is minimum and 10 is maximum intensity of symptoms) )
Measured: at 15 days
Cessation of pruritus
number of patients with a pruritus intensity at 0/10 on the VAS (Visual Analogue Scale wich measure the intensity of symptoms of pruritus, 0 is minimum and 10 is maximum intensity of symptoms))
Measured: at 60 days
Time observed to decreased the VAS to 3/10
number of days to obtain an intensity of pruritus at 3/10 on the VAS (Visual Analogue Scale )
Measured: 01 to 60 days
Duration of treatment effectiveness
number of days the VAS (Visual Analogue Scale ) is below (or equal) 3/10
Measured: 1 to 60 days
Adverse event occurring during the association therapeutic
type of adverse event occuring during the treatment period
Measured: at 15 days
Number of prematurely discontinued anti-pruritic treatment
Total number of prematurely discontinued treatments for all subjects
Measured: at 15 days
Complete blood count (normal or abnormal)
number of patients with hematologic remission : hematocrit <45% with leukocytes <10 giga/l and platelets <400 giga/l
Measured: 1 to 60 days
Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
Evaluation of quality of life by completion of the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form calculated as the mean score for 10 items. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers) questionnaire
Measured: at J0 (day of inclusion)
Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
Evaluation of quality of life by completion of the PASYMPLE (evaluation of pruritus with 7 questions about occurence, timing, intensity and localisation of pruritus) questionnaire
Measured: at J0 (day of inclusion)
Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
Evaluation of quality of life by completion of the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form calculated as the mean score for 10 items. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers)questionnaire
Measured: at 15 days
Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
Evaluation of quality of life by completion of the PASYMPLE (evaluation of pruritus with 7 questions about occurence, timing, intensity and localisation of pruritus) questionnaire
Measured: at 15 days
Quality of life through the use of validated questionnaires : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
Evaluation of quality of life by completion of the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form calculated as the mean score for 10 items. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers) questionnaire
Measured: at 30 days
Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
Evaluation of quality of life by completion of the PASYMPLE (evaluation of pruritus with 7 questions about occurence, timing, intensity and localisation of pruritus) questionnaire
Measured: at 30 days
Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
Evaluation of quality of life by completion of the MPN-SAF(Myeloproliferative Neoplasm Symptom Assessment Form calculated as the mean score for 10 items. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers) questionnaire
Measured: at 45 days
Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
Evaluation of quality of life by completion of the PASYMPLE (evaluation of pruritus with 7 questions about occurence, timing, intensity and localisation of pruritus) questionnaire
Measured: at 45 days
Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
Evaluation of quality of life by completion of the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form calculated as the mean score for 10 items. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers) questionnaire
Measured: at 60 days
Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
Evaluation of quality of life by completion of the PASYMPLE (evaluation of pruritus with 7 questions about occurence, timing, intensity and localisation of pruritus) questionnaire
Measured: at 60 days
Quantification of the change of plasma concentrations of cytokines and neuropeptides
Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)
Measured: at J0 (day of inclusion)
Quantification of the change of plasma concentrations of cytokines and neuropeptides
Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)
Measured: at 15 days
Quantification of the change of plasma concentrations of cytokines and neuropeptides
Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)
Measured: at 30 days
Quantification of the change of plasma concentrations of cytokines and neuropeptides
Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)
Measured: at 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start16 Apr 2019
- Primary completion1 Sep 2023
- Study completion22 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myeloproliferative DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 3, randomized prospective study, double blind-double placebo
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe IANOTTO, MD, PhD, Principal investigator, Hématologie Clinique-Institut de Cancéro-Hématologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808805
- Sponsor's protocol ID
- ApHyPAP 29BRC18.0036
- Other IDs
- 2018-000426-66, 2018
- Acronym
- APHYPAP
- Status last verified
- Aug 2024
- First submitted
- 26 Sep 2018
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34923994
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aprepitant Versus Hydroxyzine in Association With Cytoreductive Treatments for Patients With Myeloproliferative Neoplasia Suffering From Persistent Aquagenic Pruritus.
- ClinicalTrials.gov ID
- NCT03808805
- Acronym / sponsor ID
- APHYPAP / ApHyPAP 29BRC18.0036
- Conditions
- Myeloproliferative Disorder, Aquagenic Pruritus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Phase 3, randomized prospective study, double blind-double placebo
| Arm | Type | Receives |
|---|---|---|
| studied group | Experimental | Drug: Aprepitant 80 mg, Drug: Placebo of HydroxyzineAprepitant 80 mg daily - 14 days Plus placebo of Hydroxyzine - 14 days |
| comparative group | Active comparator | Drug: Hydroxyzine 25mg, Drug: Placebo of AprepitantHydroxyzine 25 mg/d - 14 days Plus placebo of Aprepitant - 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aprepitant 80 mgoral therapy - daily dose - 14 days | Drug | studied group |
| Hydroxyzine 25mgoral therapy - daily dose - 14 days | Drug | comparative group |
| Placebo of Hydroxyzineoral therapy - daily dose - 14 days | Drug | studied group |
| Placebo of Aprepitantoral therapy - daily dose - 14 days | Drug | comparative group |
Primary outcome
Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale )
Time frame: at 15 days
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)
22 secondary outcomes
Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale )
Time frame: at 60 days
Cessation of pruritus
Time frame: at 15 days
Cessation of pruritus
Time frame: at 60 days
Time observed to decreased the VAS to 3/10
Time frame: 01 to 60 days
Duration of treatment effectiveness
Time frame: 1 to 60 days
Adverse event occurring during the association therapeutic
Time frame: at 15 days
Number of prematurely discontinued anti-pruritic treatment
Time frame: at 15 days
Complete blood count (normal or abnormal)
Time frame: 1 to 60 days
Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
Time frame: at J0 (day of inclusion)
Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
Time frame: at J0 (day of inclusion)
Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
Time frame: at 15 days
Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
Time frame: at 15 days
Quality of life through the use of validated questionnaires : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
Time frame: at 30 days
Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
Time frame: at 30 days
Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
Time frame: at 45 days
Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
Time frame: at 45 days
Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire
Time frame: at 60 days
Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire
Time frame: at 60 days
Quantification of the change of plasma concentrations of cytokines and neuropeptides
Time frame: at J0 (day of inclusion)
Quantification of the change of plasma concentrations of cytokines and neuropeptides
Time frame: at 15 days
Quantification of the change of plasma concentrations of cytokines and neuropeptides
Time frame: at 30 days
Quantification of the change of plasma concentrations of cytokines and neuropeptides
Time frame: at 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Derived from this study: PubMed 34923994Le 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Christophe IANOTTO, MD, PhD principal investigator
Hématologie Clinique-Institut de Cancéro-Hématologie
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aprepitant 80 mg and Hydroxyzine 25mg in people with Myeloproliferative Disorder and Aquagenic Pruritus, run by University Hospital, Brest at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale ) (time frame: at 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03808805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.