Clinical Trials Register

Summary
EudraCT Number:	2015-005276-14
Sponsor's Protocol Code Number:	RGCH004
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:	2017-04-11
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

2015-005276-14

A.3

Full title of the trial

Prolonging the response by low-dose Rituximab maintenance therapy in immune thrombocytopenia: a randomized placebo-controlled trial- the PROLONG trial.

Prolongation de la réponse thérapeutique par une faible dose de rituximab en traitement d’entretien dans le « Purpura Thrombopénique Immunologique » (PTI) : étude randomisée, contrôlée versus placebo

A.3.1

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

Maintenance treatment with rituximab in ITP

Traitement de Maintenance avec le Rituximab dans le « Purpura Thrombopénique Immunologique » (PTI)

A.3.2

Name or abbreviated title of the trial where available

PROLONG-trial

Etude PROLONG

A.4.1

Sponsor's protocol code number

RGCH004

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	Sykehuset Østfold HF
B.1.3.4	Country	Norway
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	Helse Sør Øst (South-Eastern Norway Regional Health Authority
B.4.2	Country	Norway
B.4.1	Name of organisation providing support	Sykehuset Østfold HF
B.4.2	Country	Norway
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Sykehuset Østfold HF
B.5.2	Functional name of contact point	Waleed Ghanima
B.5.3	Address:
B.5.3.1	Street Address	Kalnesveien 300
B.5.3.2	Town/ city	PB 300, Grålum
B.5.3.3	Post code	1714
B.5.3.4	Country	Norway
B.5.4	Telephone number	+4741303440
B.5.6	E-mail	Waleed.Ghanima@so-hf.no

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	Mabthera
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	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	Neofordex
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratoires CTRS
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.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DEXAMETHASONE
D.3.9.1	CAS number	50-02-2
D.3.9.4	EV Substance Code	SUB07017MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
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	Concentrate for solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Immune thrombocytopenia

Purpura thrombopénique immunologique

E.1.1.1

Medical condition in easily understood language

An autoimmune disease charcaterized by low platelet count and increased risk of bleeding

Une maladie auto-immune caractérisée par une diminution du nombre de plaquettes augmentant le risque de saignement

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	19.1
E.1.2	Level	LLT
E.1.2	Classification code	10021245
E.1.2	Term	Idiopathic thrombocytopenic purpura
E.1.2	System Organ Class	100000004851

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine if maintenance therapy with low-dose rituximab is superior to placebo in prolonging responses among ITP patients who achieved an initial response with rituximab.

Déterminer si le traitement d’entretien avec une faible dose de rituximab est supérieur au placebo dans la prolongation de la réponse thérapeutique chez les patients atteints de PTI et ayant répondu à un traitement de seconde intention par rituximab

E.2.2

Secondary objectives of the trial

1. To explore if the initial overall response rate, at week 24, can be improved by at least 10% by adding dexamethasone to rituximab (induction phase).
2. To assess the safety of study treatment, especially infectious episodes (induction & maintenance phases).
3. To assess bleeding complications during the study (induction & maintenance phases).
4. To assess the use of rescue medications and other platelet-elevating therapies during the study (induction & maintenance phases).
5. To determine rate of Complete Response (CR) during induction phase and sustained CR during maintenance phase (induction & maintenance phases).
6. To determine the duration of overall response and CR (induction & maintenance phases).
7. To assess health-related quality of life and fatigue (induction & maintenance phases).

1. Estimer si le taux global de réponse initiale, à la semaine 24, peut être amélioré d’au moins 10% en ajoutant de la dexaméthasone au rituximab (phase d’induction).
2. Evaluer la sécurité du traitement à l’étude, en particulier les épisodes infectieux (phases d’induction et d’entretien).
3. Evaluer les complications hémorragiques lors de l’étude (phases d’induction et d’entretien).
4. Evaluer l’utilisation des médicaments de « secours » et autres thérapies d’augmentation du taux de plaquettes (phases d’induction et d’entretien).
5. Déterminer le taux de Réponse Complète (RC) pendant la phase d’induction et le taux de prolongation de RC pendant la phase d’entretien.
6. Déterminer la durée de la réponse globale et de la RC (phases d’induction et d’entretien).
7. Evaluer la qualité de vie et la fatigue (phases d’induction et d’entretien).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

First randomization (Induction phase)
1. Male or female aged ≥18 years.
2. Diagnosis of primary ITP of less than one year duration and having a platelet count of ≤ 30 x109/L measured within 4 weeks prior to inclusion with failure to achieve response or relapse after one cycle of dexamethasone (40 mg daily for 4 days) or after 3 to 4 weeks under any other steroid (prednisone or prednisolone). Platelet count between 31 to 50 x109/L is accepted if higher platelet count is required due to concomitant antiplatelet therapy or bleeding.
3. Scheduled intravenous treatment of rituximab.
4. Signed and dated written informed consent.
5. Females of child-bearing potential accepting to follow effective contraceptive methods for at least 12 months following the last administration of rituximab or placebo.
Second randomization (maintenance phase)
1. Completion of the induction phase (phase 1) of the study.
2. Sustained response at the end of phase 1.
3. Randomization within 4 weeks after the completion of phase 1, i.e. between week 24 and 28.

Première randomisation (phase d’induction)
1. Homme ou femme âgés de 18 ans ou plus.
2. Diagnostic de PTI primaire datant de moins d’un an et avec une numération plaquettaire ≤ 30 x109 /L dans les 4 semaines précédant l’inclusion, avec un échec de réponse ou une rechute après un cycle de dexamethasone (40mg/jour pendant 4 jours) ou après 3-4 semaines de traitement par un autre corticoïde (prednisone ou prednisolone). Une numération plaquettaire entre 31 et 50 x109/L est acceptée si un taux de plaquette plus élevé est nécessaire du fait d’une thérapie antiplaquettaire concomitante ou de saignements.
3. Traitement intraveineux de rituximab prévu.
4. Consentement éclairé signé et daté.
5. Femmes en âge de procréer acceptant l’utilisation d’une méthode contraceptive efficace pendant au moins 12 mois après la dernière administration de rituximab ou de placebo.
Deuxième randomisation (phase d’entretien)
1. Phase d’induction (phase 1) de l’étude achevée.
2. Réponse induite par le traitement maintenue à la fin de la phase 1.
3. Randomisation dans les 4 semaines après la fin de la phase 1, à savoir entre les semaines 24 et 28.

E.4

Principal exclusion criteria

First randomization (Induction phase)
1. Previous treatment for ITP with: rituximab, other immune suppressants (including mycophenolate mofetil, azathioprin, cyclosporine), chemotherapy or splenectomy.
2. Pregnancy or lactation.
3. Known active gastro-duodenal ulcer.
4. Secondary ITP: ITP associated with lymphoma, chronic lymphocytic leukemia, autoimmune disorders such as autoimmune thyroid diseases, common variable immune deficiency, human immunodeficiency virus, hepatitis C or thrombocytopenia associated with myeloid dysplasia.
5. Concomitant autoimmune hemolytic anemia.
6. History of any major cardiovascular event within the 6 months prior to randomization, including but not limited to: myocardial infarction, unstable angina, cerebrovascular accident, or New York Heart Association Class III or IV heart failure.
7. Active hepatitis B virus or patients with positive HBsAG or HBcAB.
8. Patients with active severe infection, including systemic mycotic infections or a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection.
9. Known allergy and/or sensitivity or contraindication to rituximab or dexamethasone or any of the ingredients.
10. Patients in a severely immune compromised state.
11. Known contraindication to a treatment with any proton-pump inhibitor.
12. Active malignancy or history of malignant disease during the last 2 years except cured skin cancer.
13. Patients with history of poor compliance or history of alcohol/drug abuse or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent. .
Second randomization (maintenance phase)
14. Severe allergic reaction or serum sickness due to rituximab in phase 1 of the study.
15. Pregnancy.
16. Treatment with rescue medication after week 12.
17. Patients refusing to continue in the study (withdrawal of consent).
18. Splenectomy performed for any cause.

Première randomisation (phase d’induction)
1. Traitement antérieur pour un PTI par : rituximab, autres immunosuppresseurs (y compris mycophénolate mofétil, azathioprine, cyclosporine), chimiothérapie ou splénectomie.
2. Femmes enceintes ou allaitantes.
3. Ulcère gastroduodénal évolutif connu.
4. PTI secondaire : PTI associé à un lymphome, une leucémie lymphocytaire chronique, des troubles auto-immuns comme les maladies thyroïdiennes auto-immunes, les déficits immunitaires courants, le virus de l’immunodéficience humaine (VIH), l’hépatite C, ou une thrombocytopénie associée à une myélodysplasie.
5. Anémie auto-immune hémolytique concomitante.
6. Antécédent d’événement cardiovasculaire majeur dans les 6 mois précédant la randomisation, y compris mais pas seulement : infarctus du myocarde, angor instable, accident vasculaire cérébral, ou insuffisance cardiaque de classe III ou IV (selon les critères de la New York Heart Association).
7. Patients atteints du virus de l’hépatite B ou avec antigène ou anticorps HBs positifs.
8. Patients avec une infection sévère active, y compris les infections fongiques systémiques ou les infections chroniques ou récidivantes ou toute autre pathologie sous-jacentes pouvant prédisposer à une infection grave.
9. Allergie et/ou hypersensibilité connue ou contre indication au rituximab, à la dexaméthasone ou aux excipients.
10. Patients dont l’état immunitaire est gravement atteint.
11. Contre-indication connue à un traitement avec un inhibiteur de la pompe à proton.
12. Tumeur maligne active ou antécédent d’affection maligne au cours des 2 dernières années à l’exception d’un cancer de la peau guéri.
13. Patients avec antécédent de mauvaise observance ou d’abus d’alcool/drogues ou de consommation excessive d’alcool qui pourraient altérer la capacité à se conformer au protocole de l’étude, ou de trouble psychiatrique actuel ou passé qui peut altérer la capacité à se conformer au protocole de l’étude ou à donner son consentement éclairé.

Deuxième randomisation (phase d’entretien)
1. Réaction allergique grave ou maladie sérique causée par le rituximab durant la phase d’induction (phase 1) de l’étude.
2. Grossesse.
3. Traitement avec un médicament de secours après la semaine 12.
4. Patients refusant de continuer l’étude (retrait du consentement).
5. Splénectomie pratiquée pour n’importe quelle indication.

E.5 End points

E.5.1

Primary end point(s)

Sustained overall response during maintenance phase [loss of overall response is defined as: (1) two consecutive measurements with platelet counts < 50 x 109/L taken at 1-8-week interval, and/or, (2) use of any ITP-directed therapies, other than study medication, because of bleeding or thrombocytopenia, except for preoperative elevation of platelet count] (this endpoint applies to maintenance phase only).

Réponse globale prolongée obtenue pendant la phase d’entretien. La perte de la réponse globale est définie comme : (1) deux mesures consécutives de la numération plaquettaire < 50 x109/L, prises entre 1 et 8 semaines d’intervalle, et/ou, (2) utilisation de n’importe quel traitement du PTI autre que celui à l’étude, en raison de saignement ou de thrombocytopénie, sauf dans le but d’augmenter le taux de plaquettes en préopératoire.

E.5.1.1

Timepoint(s) of evaluation of this end point

24 weeks for first randomization and 52 weeks for second randomization

24 semaines pour la première randomisation et 52 semaines pour la seconde randomisation

E.5.2

Secondary end point(s)

1. Overall response during induction phase defined as mean platelet count, determined in week 24 (± 2 weeks) after induction therapy, > 50 x 109/L , without use of any other ITP-directed therapies after week 12 following the first randomization (this endpoint applies to induction phase only).
2. Safety assessed by the frequency of > grade II adverse events (this endpoint applies to both phases).
3. Grade of bleeding (this endpoint applies to both phases).
4. Sustained Complete Response (CR) during maintenance phase defined as platelet count > 100 x 109/L maintained during maintenance phase, without the use of any ITP-directed therapies
5. Complete Response (CR) during induction phase, defined as platelet count, determined in week 24 (± 2 weeks), > 100 x 109/L without use of any other ITP-directed therapies after week 12 following the first randomization (induction phase)
6. Administration of rescue medication or other elevating platelet therapy
1. After week 12 (induction phase)
2. During maintenance phase (maintenance phase).
7. Percentage of patients with more than 80% of platelet counts level > 50 x 109/L during the maintenance phase (this endpoint applies to maintenance phase only).
8. Health-related quality of life (this endpoint applies to both phases).
9. Fatigue using an analogical scale of 0-10 (this endpoint applies to both phases) and Multidimensionnal Fatigue Inventory (MFI 20).

1. Obtention de la réponse globale au cours de la phase d’induction définie comme étant une numération plaquettaire ≥ 50 x109/L mesurée semaine 24 (± 2 semaines) après le traitement d’induction, sans aucun autre traitement du PTI après la 12e semaine suivant la première randomisation (ce critère s’applique à la phase d’induction uniquement).
2. Sécurité évaluée sur la fréquence des événements indésirables > grade II (ce critère s’applique aux 2 phases).
3. Niveau de saignement (ce critère s’applique aux 2 phases).
4. Obtention d’une Réponse Complète prolongée durant la phase d’entretien, définie comme une numération plaquettaire ≥ 100 x109/L, sans recours à aucun autre traitement du PTI.
5. Obtention de la Réponse Complète durant la phase d’induction, définie comme une numération plaquettaire ≥ 100 x109/L mesurée semaine 24 (± 2 semaines), sans recours à aucun autre traitement du PTI après la semaine 12 suivant la première randomisation (phase d’induction).
6. Administration d’un traitement de secours ou d’un autre traitement permettant d’augmenter le taux de plaquettes :
1) Après la semaine 12 (phase d’induction)
2) Pendant la phase d’entretien (phase d’entretien)
7. Pourcentage de patients ayant eu plus de 80% des mesures du taux de plaquettes ≥ 50 x109/L au cours de la phase d’entretien (ce critère s’applique à la phase d’entretien uniquement).
8. Qualité de vie mesurée grâce au questionnaire SF-36 (ce critère s’applique aux deux phases).
9. Mesure de la fatigue sur une échelle analogique allant de 0 à 10 (Ce critère s’applique aux deux phases) et du Questionnaire Multidimentionnel sur la Fatigue (version française du MFI).

E.5.2.1

Timepoint(s) of evaluation of this end point

1.Sustained overall response: 24weeks and 52 weeks for first and second randomization
2.Sustained complete response: 24 weeks and 52 weeks.
Rescue medication and remaining endpoints: 12 weeks and 52 weeks

1. Réponse globale prolongée : 24 semaines et 52 semaines pour la première et deuxième randomisation
2. Réponse complète prolongée: 24 semaines et 52 semaines.
Traitement de secours et autres critères de jugement: 12 semaines et 52 semaines.

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

Yes

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

Yes

E.6.13.1

Other scope of the trial description

mechanisms and biomarkers (CD19)

Mécanismes et biomarqueurs (CD19)

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

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Première phase: ouvert, deux bras parallèles. Deuxième phase: Double aveugle avec 2 bras parallèles

First Phase : open-label, 2 parallel arms. Second phase: double blind with 2 paralell arms

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Denmark

France

Morocco

Norway

Tunisia

United Kingdom

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

Dernière Visite Dernier Sujet

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

100

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Aucun

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

2017-04-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-03-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2024-12-31

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