Clinical Trials Register

Summary
EudraCT Number:	2018-000426-66
Sponsor's Protocol Code Number:	29BRC18.0036
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-05-30
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2018-000426-66

A.3

Full title of the trial

Aprepitant versus Hydroxyzine en association avec les traitements cytoréducteurs pour les patients avec néoplasies myéloprolifératives souffrant d’un Prurit Aquagénique Persistant.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Aprepitant versus Hydroxyzine pour le traitement du prurit aquagénique des patients avec néoplasies myéloprolifératives

A.3.2

Name or abbreviated title of the trial where available

APHYPAP

A.4.1

Sponsor's protocol code number

29BRC18.0036

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	CHRU de Brest
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Health ministry
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	CHRU de Brest
B.5.2	Functional name of contact point	Véronique Kouassi
B.5.3	Address:
B.5.3.1	Street Address	2 avenue Foch
B.5.3.2	Town/ city	Brest
B.5.3.3	Post code	29609
B.5.3.4	Country	France
B.5.4	Telephone number	00330229020120
B.5.5	Fax number	00330229020120
B.5.6	E-mail	veronique.kouassi@chu-brest.fr

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	EMEND
D.2.1.1.2	Name of the Marketing Authorisation holder	MSD France
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Aprepitant
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	ATARAX
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB Pharma
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	HYDROXYZINE
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

néoplasies myéloprolifératives avec Prurit Aquagénique Persistant

E.1.1.1

Medical condition in easily understood language

néoplasies myéloprolifératives avec Prurit Aquagénique Persistant

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	SOC
E.1.2	Classification code	10040785
E.1.2	Term	Skin and subcutaneous tissue disorders
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Démontrer la supériorité de l’Aprepitant par rapport à l’Hydroxyzine pour traiter le prurit aquagénique des patients avec NMP.

E.2.2

Secondary objectives of the trial

Evaluation du nombre de patients avec une disparition totale du PA
Evaluation du temps de réponse.
Evaluation de la durée de réponse sous et après arrêt du traitement.
Impact sur les autres symptômes généraux (asthénie, fièvre, sueurs nocturnes).
Evaluation de la qualité de vie avant-pendant et après le traitement.
Evaluation de la tolérance et identification d’effets secondaires éventuels sous les différentes associations thérapeutiques.
Impact sur la réponse hématologique (selon les critères de l’European LeukemiaNet)
Etude de la concentration des cytokines circulantes avant-pendant et après le traitement.
Etude des caractéristiques cutanées par biopsies de peau des patients NMP souffrant de PA et évaluer les modifications après traitement.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Patients de plus de 18 ans, atteints de néoplasies myéloprolifératives type polyglobulie de Vaquez, thrombocytémie essentielle ou myélofibrose.
- ET traités par hydroxyurée, pipobroman, anagrelide, interféron α2a pégylé, ruxolitinib ou saignées depuis plus de 6 mois.
- ET souffrant de prurit aquagénique malgré leur traitement cytoréducteur.
- ET ayant une intensité du prurit supérieure ou égale à 6 (sur EVA).
- Patients ayant donné leur consentement écrit pour la participation à l’étude.

E.4

Principal exclusion criteria

Patients ayant une incapacité physique ou psychologique à signer le consentement.
Patients atteints de NMP et souffrant de PA mais uniquement traités par aspirine.
Patients déjà inclus dans un autre protocole thérapeutique.
Patients souffrant d’une maladie dermatologique diffuse où un prurit peut être présent (psoriasis, dermatite atopique, prurigo…)
Patients étant déjà sous traitement anxiolytique et/ou anti-dépresseur, (critère laissé à l’appréciation du praticien.)
Patients avec contre-indications absolues à l’utilisation de l’Aprepitant ou de l’Hydroxyzine
Hypersensibilité à l’Aprepitant et/ou à l’Hydroxyzine ou à un de leurs excipients.
Intolérance au lactose.
Patientes remplissant les critères (NMP + prurit aquagénique) mais étant enceintes ou allaitantes au moment du protocole.

E.5 End points

E.5.1

Primary end point(s)

L’intensité du PA sera évaluée (entre 0 et 10) grâce à une échelle visuelle analogique (EVA). Le traitement reçu par le patient sera considéré comme efficace en cas de réduction de l’intensité du PA à 3 points (ou moins) sur l’EVA évaluée à J15
=> Le succès est donc l’obtention d’une EVA ≤3 à J15

E.5.1.1

Timepoint(s) of evaluation of this end point

Le succès est donc l’obtention d’une EVA ≤3 à J15

E.5.2

Secondary end point(s)

Réduction de l’intensité du PA à 3 points (ou moins) à J60 sur l’EVA notée de 0 à 10.
Disparition totale du PA (EVA=0) à J15 et J60
Délai observé pour diminuer l’EVA à 3 points
Durée d’efficacité du traitement (nombre de jours où l’EVA est ≤3)
Incidence et type d’effets secondaires survenant lors de l’association thérapeutique (évaluer selon les critères du CTCAE v4)
Nombre d’arrêt prématuré des médicaments anti-prurit
Qualité de vie par l’utilisation bimensuelle de questionnaires validés (MPN-SAF, PASYMPLE…)
Hémogramme (normal ou anormal)
Quantification de la réduction des concentrations plasmatiques des cytokines et des neuropeptides pouvant être impliqués dans la physiopathologie du prurit (bilan sanguins répétitifs)
Observer les changements cellulaires cutanés éventuels (par étude anatomopathologique de biopsies cutanées avant et après traitement).

E.5.2.1

Timepoint(s) of evaluation of this end point

en fin d'étude

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	80

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-07-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-06-19

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-06-08

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