Clinical Trials Register

Summary
EudraCT Number:	2010-019181-91
Sponsor's Protocol Code Number:	69HCL16_0186
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2017-05-10
Trial results	View 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

2010-019181-91

A.3

Full title of the trial

Treatment of High Grade Non-Muscle Invasive Urothelial Carcinoma of the Bladder by Standard Number and Dose of Intravesical BCG Instillations Versus Reduced Number of Intravesical Instillations with Standard Dose of BCG.
A European Association of Urology Research Foundation Randomised Phase III Clinical Trial.

Etude randomisée comparant le traitement standard de 15 instillations par BCG thérapie à un traitement allégé de 9 instillations chez les patients porteurs d’une tumeur de vessie n'infiltrant pas le muscle. Etude NIMBUS

A.3.1

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

Standard number and dose intravesical instillation therapy with BCG versus Reduced number and standard dose intravesical instillation therapy with BCG in patients with high grade non-muscle invasive urinary bladder carcinoma.

A.3.2

Name or abbreviated title of the trial where available

NIMBUS

A.4.1

Sponsor's protocol code number

69HCL16_0186

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	EAU Foundation for Urological Research
B.1.3.4	Country	Netherlands
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	EAU Foundation for Urological Research
B.4.2	Country	Netherlands
B.4.1	Name of organisation providing support	Deutsche Krebshilfe
B.4.2	Country	Germany
B.4.1	Name of organisation providing support	Association pour le Développement de la Recherche en Urologie (ADRU)
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	EAU Foundation for Urological Research
B.5.2	Functional name of contact point	Project Manager
B.5.3	Address:
B.5.3.1	Street Address	Mr. E.N. van Kleffensstraat 5
B.5.3.2	Town/ city	Arnhem
B.5.3.3	Post code	6842 CV
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	+31263890677
B.5.5	Fax number	+31263890679
B.5.6	E-mail	researchfoundation@uroweb.org

D. IMP Identification
D.IMP: 1
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	BCG-medac
D.2.1.1.2	Name of the Marketing Authorisation holder	Medac
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Intravesical solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravesical 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)	Yes
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	BCG-medac. The IMP used in this (test) study arm is the same as the (comparator) standard arm but used in a reduced frequency.
D.2.1.1.2	Name of the Marketing Authorisation holder	Medac
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Intravesical solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravesical 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)	Yes
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: 3
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	OncoTICE
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck & Co, Inc.
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	Intravesical solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravesical 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)	Yes
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: 4
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	OncoTICE. The IMP used in de (test) study arm is the same as the (comparator) standard arm but used in reduced frequency.
D.2.1.1.2	Name of the Marketing Authorisation holder	Merk & Co, Inc.
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	Intravesical solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravesical 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)	Yes
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: 5
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	IMMUCYST 81 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI PASTEUR
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	Powder for intravesical suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravesical 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)	Yes
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: 6
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	IMMUCYST 81 mg. The IMP used in this (test) study arm is the same as the (comparator) standard arm but used in a reduced frequency.
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI PASTEUR
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	Powder for intravesical suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravesical 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)	Yes
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Non muscle invasive bladder cancer after transurethral resection of the Bladder Tumor (TURT).

Patients porteurs d’une tumeur de vessie n'infiltrant pas le muscle, après résection de la tumeur vésicale

E.1.1.1

Medical condition in easily understood language

Non muscle invasive bladder cancer after transurethral resection of the Bladder Tumor (TURT).

Patients porteurs d’une tumeur de vessie n'infiltrant pas le muscle, après résection de la tumeur vésicale

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10005003
E.1.2	Term	Bladder cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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

The primary objective of this study is to identify if reduced number of BCG instillations are not inferior to standard number and dose intravesical BCG treatment in patients with high grade NMIBC. The primary endpoint for inferiority analysis is time to first recurrence.

L'objectif principal est de montrer qu'un nombre réduit d'instillations de BCG intra vésical n'est pas un traitement inférieur au traitement standard chez les patients présentant une TVNIM de haut grade

E.2.2

Secondary objectives of the trial

The secondary objectives are to identify if number and grade of recurrent tumors, rate of progression to a higher stage (T2 or higher) of the disease and safety, specifically the presence of treatment related toxicity > grade 2 differ between the two study arms.

Les objectifs secondaires sont d'identifier le nombre et le grade des tumeurs récidivantes, le taux de progression à un stade plus élevé (T2 ou plus), la toxicité > grade 2

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Presence of high grade (Ta-T1) urothelial papillary carcinoma of the bladder with or without CIS
1.1. Tumors can be primary or recurrent
1.2. Tumors can be single or multiple
2. Re-TUR should be performed at weeks 4-8 after initial resection, which must include the deep resection or cold cup biopsy (deep enough to obtain muscle tisssue) of the initial tumor site(s)
3. Re-re-TUR should be performed in case of histological detection of high grade papillary NMIBC in the re-TUR, which must include the deep resection or cold cup biopsy (deep enough to obtain muscle tisssue) of the initial tumor site(s)
4. Histopathologically confirmed absence of high-grade papillary NMIBC in the re-TUR specimen and/or re-re-TUR specimen
5. All visible papillary tumors must be completely resected
6. Early postoperative (within 6 hours of resection) single dose chemotherapy is allowed after the first resection. However, it should not be given after re-TUR if the patient is considered eligible for this study
7. Prior multi-instillation intravesical chemotherapy is allowed, provided that the last instillation was completed 3 months before randomisation in this study.
8. Signed and dated informed consent form.
9. Patient is clinically fit enough to receive BCG bladder instillations.

1. Tumeur papillaire n’infiltrant pas le muscle vésical (TVNIM Ta-T1) ou sans CIS
1.1. Les tumeurs peuvent être primitives ou récidivantes
1.2. Les tumeurs peuvent être simples ou multiples
2. Nouvelle résection (re-REUV) de contrôle qui doit être réalisée 4-8 après résection initiale, par résection profonde ou une biopsie (assez profonde pour obtenir du tissu musculaire) du site de la tumeur initiale (s)
3. Une nouvelle re-REUV doit être effectuée en cas de détection de carcinome de haute grade ou de TVNIM dans la re-REUV, par résection profonde ou une biopsie (assez profonde pour obtenir du tissu musculaire) du site de la tumeur initiale(s)
4. L’examen histologique a confirmé l'absence de tumeur papillaire de haut grade dans l'échantillon des nouvelles résections
5. La résection de toutes les tumeurs papillaires visibles doit être complète
6. la chimiothérapie post opératoire précoce à dose unique (dans les 6 heures après la résection) est autorisée mais ne doit pas être faite après re-TUR si le patient est considéré comme admissible à cette étude
7. Le traitement par instillation intravésicale par chimiothérapie est autorisé, à condition que la dernière instillation ait été achevée 3 mois avant la randomisation dans cette étude.
8. consentement éclairé signé et daté.
9. Le patient est cliniquement apte à être traité par instillations de BCG

E.4

Principal exclusion criteria

1. Any previous intravesical BCG therapy
2. Presence of primary CIS only.
3. Presence of histopathologically proven muscle invasive urothelial carcinoma of the bladder at first or re-TUR surgical specimens
4. Patients with incomplete resection of visible tumors
5. Absence of muscle tissue in the re-TUR specimen(s)
6. Presence of any upper urinary tract tumors at any time
7. Presence of any other histological type of resected tumor other than urothelial carcinoma on the first or second resection
8. Presence of another malignancy other than the basal cell carcinoma of the skin or localised prostate cancer in active surveillance
9. Presence of pregnancy or lactation
10. Presence of active tuberculosis, any form of immunodeficiency (eg HIV + serology, transplant recipients) and/or any other contraindication of BCG therapy
11. Patients who have received any systemic cytostatic agents within the last 3 months
12. Patients with uncontrollable UTI

1. Tout traitement préalable par BCG intravésical
2. Diagnostic de CIS primaire.
3. Infiltration du muscle vésical prouvé histologiquement au premier ou aux re-REUV.
4. Résection incomplète de tumeurs visibles
5. Absence de tissu musculaire dans les échantillons des re-TUR (s)
6. Présence de toutes les tumeurs des voies urinaires supérieures à tout moment
7. La présence d'un autre type histologique d'une tumeur réséquée autre que le carcinome urothélial de la première ou de la deuxième résection
8. La présence d'une autre tumeur maligne autre que le carcinome basocellulaire ou de cancer de la prostate localisé en surveillance active
9. grossesse ou allaitement
10. Tuberculose active, toute forme d'immunodéficience (VIH + sérologie, les receveurs de greffe) et / ou tout autre contre-indication de la thérapie BCG
11. Les patients traités par cytostatiques systémiques dans les trois derniers mois
12. Patients ayant une infection urinaire non contrôlable

E.5 End points

E.5.1

Primary end point(s)

Time to first recurrence.

Délai de survenue de la première récidive

E.5.1.1

Timepoint(s) of evaluation of this end point

Timepoint after randomisation at which the date of first recurrence of the disease occurs up to a maximum of 5 years from the first administration of BCG Vaccine for intravesical instillation.

Date d'apparition de la première récidive de la maladie à partir de la randomisation, et jusqu'à 5 ans à compter de la première administration de vaccin BCG pour instillation intra vésicale

E.5.2

Secondary end point(s)

Number and grade of recurrent tumors.
Rate of progression to a higher stage (T2 or higher).
Incidence and severity of side effects, specifically the presence of treatment related toxicity > Grade 2.

Nombre et grade des tumeurs récidivantes;
Fréquence de progression à un stade supérieur (T2 ou plus)
Incidence et sévérité des effets secondaires, en particulier présence de toxicité liée au traitement > grade 2

E.5.2.1

Timepoint(s) of evaluation of this end point

Timepoint after randomisation at which the date of first recurrence of the disease occurs up to a maximum of 5 years from the first administration of BCG Vaccine for intravesical instillation.

Depuis la randomisation et jusqu'à l'apparition de la première récidive de la maladie, au maximum jusqu'à 5 ans à compter de la première administration de vaccin BCG pour instillation intra vésicale.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

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

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Nombre et dose standard d'instillations BCG

Standard number and Dose of BCG instillations

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

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

Last visit of the last patient.

Dernière visite du dernier patient

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

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:

100

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

200

F.4.2

For a multinational trial

F.4.2.1

In the EEA

824

F.4.2.2

In the whole clinical trial

824

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. After recurrence, treatment will be performed according to the discretion of the treating physician.

Aucun. Après la récidive, la prise en charge du patient sera laissée à la discrétion de son médecin traitant.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-05-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-01-25

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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