Clinical Trials Register

Summary
EudraCT Number:	2016-002972-29
Sponsor's Protocol Code Number:	CART19-BE-01
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-01-04
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

Spain - AEMPS

A.2

EudraCT number

2016-002972-29

A.3

Full title of the trial

Pilot study on the infusion of differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity (A3B1) conjugated with the co-stimulatory regions 4-1BB and CD3z (ARI-0001 cells) in patients with CD19+ leukemia or lymphoma refractory to therapy

Estudio piloto de la infusión de linfocitos T diferenciados autólogos de sangre periférica expandidos y transducidos con un lentivirus para expresar un receptor antigénico quimérico con especificidad anti-CD19 (A3B1) conjugado con las regiones coestimuladoras 4-1BB y CD3z (células ARI-0001) en pacientes con leucemia o linfoma CD19+ resistente o refractaria a tratamiento

A.3.1

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

Pilot study on the infusion of ARI-0001 cells in patients with CD19+ leukemia or lymphoma refractory to therapy

Estudio piloto de la infusión de células ARI-0001en pacientes con leucemia o linfoma CD19+ resistente o refractaria a tratamiento

A.3.2

Name or abbreviated title of the trial where available

CART19-BE-01

A.4.1

Sponsor's protocol code number

CART19-BE-01

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	IDIBAPS
B.1.3.4	Country	Spain
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	Instituto de Salud Carlos III
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Hospital Clínic
B.5.2	Functional name of contact point	Judit Pich Martinez
B.5.3	Address:
B.5.3.1	Street Address	Mallorca, 183 sotano despacho 58, Entregar de 9 a 17h
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08036
B.5.3.4	Country	Spain
B.5.4	Telephone number	+349322754002946
B.5.5	Fax number	+34932279877
B.5.6	E-mail	jdelgado@clinic.cat

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	No
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	ARI-0001
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravascular use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Adult differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with a
D.3.9.2	Current sponsor code	ARI-0001
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.5 to 10
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)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Yes
D.3.11.3.1	Somatic cell therapy medicinal product	Yes
D.3.11.3.2	Gene therapy medical product	Yes
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	Yes
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

Patients with leukemia or lymphoma refractory to therapy

Pacientes con leucemia o linfoma resistente o refractaria al tratamiento

E.1.1.1

Medical condition in easily understood language

Leukemia o lymphoma

Leucemia o linfoma

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	19.0
E.1.2	Level	PT
E.1.2	Classification code	10061275
E.1.2	Term	Mantle cell lymphoma
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	LLT
E.1.2	Classification code	10008957
E.1.2	Term	Chronic lymphatic leukemia
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	LLT
E.1.2	Classification code	10029473
E.1.2	Term	Nodular (follicular) lymphoma
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	LLT
E.1.2	Classification code	10000843
E.1.2	Term	Acute lymphatic leukemia
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

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the infusion of ARI-0001 cells (Adult differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity [A3B1] conjugated with the co-stimulatory regions 4-1BB and CD3z ) safety on patients with leukemia or lymphoma CD19+ resistant or refractory to treatment and with a prognosis of less than 2 years.

Evaluar la seguridad de la infusión de células ARI-0001 (linfocitos T diferenciadas adultas
autólogas de sangre periférica expandidas y transducidas con un lentivirus para expresar un
receptor antigénico quimérico con especificidad anti-CD19 [A3B1] conjugado con las regiones
coestimuladoras 4-1BB y CD3z) en pacientes con leucemia o linfoma CD19+ resistente o
refractario al tratamiento y con un pronóstico inferior a 2 años

E.2.2

Secondary objectives of the trial

• Evaluate the infusion of ARI-0001 effectiveness
• Evaluate the duration of the infusion of ARI-0001
• Evaluate the overall survival after the infusion of ARI-0001
• Evaluate the duration of ARI-0001 cells in peripheral blood, bone marrow and CSF after administration
• Evaluate the effect of ARI-0001 treatment on patients quality of life
• Assess adverse events occurring at 3 months and at the first year.

Evaluar la eficacia de la infusión de ARI-0001
• Evaluar la duración de la respuesta tras la infusión de ARI-0001
• Evaluar la supervivencia global tras la infusión de ARI-0001
• Evaluar la duración de las células ARI-0001 en sangre periférica, médula ósea y LCR tras
su administración
• Evaluar el efecto del tratamiento con ARI-0001 sobre la calidad de vida de los pacientes
• Evaluar los acontecimientos adversos ocurridos a los 3 meses y al año

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Diagnosis of leukemia or CD19 + lymphoma, with a life expectancy less than 2 years that meet the following conditions:
Adult acute lymphoid leukemia in second or third response, not candidate for transplantation due to age, associated diseases or lack of donor, or in relapse post allogeneic transplant.
Pediatric acute lymphoid leukemia in second or third response, refractory or non-transplant candidate due to donor absence, or in relapse post allogeneic transplant, or with minimal residual residual disease (0.1% or greater) after two or more lines of treatment.
Symptomatic follicular lymphoma, which has received at least 2 treatment regimens (one of them including rituximab) and a progression-free interval of less than 2 years. Patients not candidates for transplantation or post-transplant relapse may be included.
Symptomatic chronic lymphocytic leukemia, which has received at least 2 treatment regimens (one of them including rituximab) and a progression-free survival of less than 2 years. Patients with a 17p deletion or TP53 mutation may be included after the first line of treatment.
Mantle cell lymphoma in the first relapse (or higher) when it is not a candidate for transplantation, or second post-transplant relapse (or higher).
Diffuse large cell lymphoma in first relapse (or higher) when it is not a candidate for transplantation, or second post-transplant relapse (or higher).
2. Age greater than 2 years and less than 80.
3. ECOG functional status from 0 to 2 (Annex II).
4. Life expectancy of at least 3 months.
5. Appropriate venous access to perform an apheresis procedure. Absence of contraindications for it.
6. Signature of informed consent (patient or legal guardian).

1. Diagnóstico de leucemia o linfoma CD19+, con un pronóstico vital inferior a 2 años que
cumplan con las siguientes condiciones:
- Leucemia linfoide aguda del adulto en segunda o tercera respuesta, no candidato a
trasplante por edad, enfermedades asociadas o ausencia de donante, o en recaída posttrasplante
alogénico.
- Leucemia linfoide aguda pediátrica en segunda o tercera respuesta, refractaria o no
candidato a trasplante por ausencia de donante, o en recaída post-trasplante alogénico,
o enfermedad mínima residual elevada (0,1% o mayor) tras dos o más líneas de
tratamiento.
- Linfoma folicular sintomático, que ha recibido al menos 2 esquemas de tratamiento (uno
de ellos incluyendo rituximab) y con un intervalo libre de progresión inferior a 2 años.
Podrán incluirse pacientes no candidatos a trasplante o en recaída post-trasplante.
- Leucemia linfática crónica sintomática, que al menos ha recibido 2 esquemas de
tratamiento (uno de ellos incluyendo rituximab) y con un intervalo libre de progresión
inferior a 2 años. Los pacientes con deleción de 17p o mutación de TP53 podrán incluirse
tras la primera línea de tratamiento.
- Linfoma del manto en primera recaída (o superior) que no es candidato a trasplante, o
bien en segunda recaída (o superior) post-trasplante.
- Linfoma difuso de células grandes en primera recaída (o superior) que no es candidato a
trasplante, o bien en segunda recaída (o superior) post-trasplante.
2. Edad superior a 2 años e inferior a 80 años.
3. Estado funcional ECOG de 0 a 2 (Anexo II).
4. Esperanza de vida de al menos 3 meses.
5. Acceso venoso adecuado para realizar una linfoaféresis. Ausencia de contraindicaciones
para la misma.
6. Firma del consentimiento informado (paciente o tutor legal).

E.4

Principal exclusion criteria

1. Treatment with any experimental or non-marketed substance within four weeks prior to recruitment, or actively participating in another therapeutic clinical trial.
2. Diagnosis of another past or present neoplasm. Patients may be included in complete remission for more than 3 years, or with a history of non-melanoma skin cancer or completely resected in-situ carcinoma.
3. Central nervous system involvement (CNS-3) at inclusion. Inclusion will be permitted with patients with a lower grade (CNS-2) or with CNS-3 who have responded to intrathecal chemotherapy.
4. Early relapse after allogeneic transplantation (less than 3 months for apheresis of mononuclear cells, less than 6 months for infusion of ARI-0001) or patients on active immunosuppressive therapy for graft-versus-host disease (corticosteroids or other systemic immunosuppressants ).
5. Active infection requiring systemic medical treatment such as chronic kidney infection, chronic lung infection or tuberculosis.
6. HIV infection.
7. Concurrent and uncontrolled medical illnesses including cardiac, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological or psychiatric diseases which in the opinion of the researcher represent a risk to the patient.
8. Positive serology for hepatitis B, defined as a positive test for HBsAg. In addition, if the patient is HBsAg negative but has anti-HBc antibodies it will be necessary to perform a DNA test of the hepatitis B virus, and if the result is positive the patient will be excluded.
9. Positive serology for hepatitis C, defined as a positive test for anti-HCV antibodies confirmed by RIBA.
10. Severe organ failure, defined as a cardiac ejection fraction <40%; DLCO <40%; calculated glomerular filtrate rate <30 ml / min; Or bilirubin> 3 times the upper limit of normal (unless it is due to CLL or Gilbert syndrome).
11. Pregnant or lactating women. Women of childbearing potential should have a negative pregnancy test in the screening phase.
12. Women of childbearing age, including those whose last menstrual cycle was in the year prior to screening, who are unable or unwilling to use highly effective contraceptive methods * from the start of the study to the end of the study.
13. Men who are unable or unwilling to use highly effective contraceptive methods * from the start of the study to the completion of the study.
14. The need to take glucocorticoids in a chronic manner at doses higher than 10 mg / day of prednisone (or equivalent) or other chronic immunosuppressants.

* Hormonal contraceptives, intrauterine device, intrauterine systems of hormonal release, sexual abstinence, vasectomy of the couple or bilateral tubal occlusion.

1. Tratamiento con cualquier sustancia experimental o no comercializada en las cuatro
semanas previas al reclutamiento, o que esté participando activamente en otro ensayo
clínico terapéutico.
2. Diagnóstico de otra neoplasia, pasada o actual. Podrán incluirse pacientes que lleven en
remisión completa más de 3 años, o con antecedentes de cáncer cutáneo no melanoma o
carcinoma in situ resecado completamente.
3. Afectación franca del sistema nervioso central (SNC-3) en el momento de la inclusión. Se
permitirá la inclusión con pacientes con un grado menor (SNC-2) o con SNC-3 que haya
respondido a quimioterapia intratecal.
4. Recaída precoz tras trasplante alogénico (menos de 3 meses para la aféresis de células
mononucleadas, menos de 6 meses para la infusión de ARI-0001) o pacientes que estén en
tratamiento inmunosupresor activo por enfermedad injerto contra huésped (corticoides u
otros inmunosupresores sistémicos).
5. Infección activa que requiere tratamiento médico sistémico como, por ejemplo, infección
renal crónica, infección pulmonar crónica o tuberculosis.
6. Infección por VIH.
7. Enfermedades médicas concurrentes e incontroladas incluyendo enfermedades cardiacas,
renales, hepáticas, gastrointestinales, endocrinas, pulmonares, neurológicas o
psiquiátricas que en opinión del investigador supongan un riesgo para el paciente.
8. Serología positiva para hepatitis B, definida como prueba positiva para HBsAg. Además, si
el paciente es HBsAg negativo pero tiene anticuerpos anti-HBc será necesario realizar un
test de ADN del virus de la hepatitis B, y si el resultado es positivo el paciente será
excluido.
9. Serología positiva para hepatitis C, definida como prueba positiva para anticuerpos anti-
VHC que se confirma mediante RIBA.
10. Afectación orgánica grave, definida como fracción de eyección cardíaca <40%; DLCO
<40%; filtrado glomerular calculado <30 ml/min; o bilirrubina > 3 veces el límite superior
de la normalidad (a menos que se deba a la LLC o a un síndrome de Gilbert).
11. Mujeres embarazadas o lactando. Las mujeres en edad fértil deberán tener una prueba
de embarazo negativa en la fase de screening.
12. Mujeres en edad fértil, incluyendo aquellas cuyo último ciclo menstrual fue en el año
previo al cribado, que no puedan o no deseen emplear métodos anticonceptivos
altamente eficaces* desde el inicio del estudio hasta la finalización del mismo.
13. Varones que no puedan o no deseen emplear métodos anticonceptivos altamente
eficaces* desde el inicio del estudio hasta la finalización del mismo.
14. Necesidad de tomar glucocorticoides de manera crónica en dosis superior a 10 mg/día de
prednisona (o equivalentes) u otros inmunosupresores crónicos.
* anticonceptivos hormonales, dispositivo intrauterino, sistemas intrauterino de liberación hormonal,
abstinencia sexual, vasectomía de la pareja o oclusión tubárica bilateral.

E.5 End points

E.5.1

Primary end point(s)

To assess the infusion of ARI-0001 cells safety on the basis of the following parameters:
- Procedure-related mortality (PRM) at the first and third year, defined as any death not caused directly by leukemia / lymphoma. For the estimation of PRM, relapse or progression of the disease will be considered as a competitive event.
- Assessment of toxicity at 3 months and first year, defined as number of adverse events grade III-IV using CTC (common toxicity criteria) version 3.0. Particular attention will be paid to cytokine release syndrome, neurological toxicity and the occurrence of second malignancies.

Evaluar la seguridad de la infusión de células ARI-0001 en base a los siguientes parámetros:
- Mortalidad relacionada con el procedimiento (MRP) al año y los 3 años, definida como
cualquier fallecimiento no causado directamente por la leucemia/linfoma. Para la
estimación de la MRP se considerará la recaída o progresión de la enfermedad como un
evento competitivo.
- Evaluación de la toxicidad a los 3 meses y al año, definida como número de
acontecimientos adversos grado III-IV empleando los CTC (common toxicity criteria)
versión 3.0. Se prestará especial atención al síndrome de liberación de citocinas, la
toxicidad neurológica y a la aparición de segundas neoplasias.

E.5.1.1

Timepoint(s) of evaluation of this end point

Month 3, year 1 and year 3

Mes 3, 1 año y 3 años

E.5.2

Secondary end point(s)

- Response rate (overall and complete) at 3 months and first year, defined differently for each disease.
o On chronic lymphoid and acute lymphocytic leukemia, the usual criteria NCCN and IWCLL will be used.
o On non-Hodgkin's lymphoma, the Lugano criteria will be used.
o On patients with leukemia will be quantified the persistence of minimal residual disease, in bone marrow and peripheral blood, using multiparametric cytometry and new generation sequencing techniques.
- Progression-free survival at 2 years after the procedure, defined as the time lag between infusion of ARI-0001 and the progression of disease or death. Patients alive and in complete remission will be censored at the last follow-up.
- Overall survival (OS) at 2 years, defined as the time lag between the infusion of ARI-0001 and the death of the patient from any cause. Living patients will be censored at the the last follow-up.
- In vivo survival of ARI-0001 cells in peripheral blood, bone marrow and cerebrospinal fluid, determined, monthly during the first 6 months and thereafter quarterly until the 2 years after infusion, by flow cytometry and quantitative transgene PCR.
- Quality of life of included patients, evaluated by a questionnaire completed by patients or their legal guardians at 3 and 6 months and a year after.
- Toxicity assessment at 3 months and a year after, defined as number of adverse events of any type occurring throughout the study using the common toxicity criteria (version 3.0)

- Tasa de respuestas (globales y completas) a los 3 meses y al año, definida de manera
diferente para cada enfermedad.
o Leucemia linfoide aguda y linfática crónica se emplearán los criterios habituales
NCCN y IWCLL.
o Linfoma no-Hodgkin se emplearán los criterios de Lugano.
o En los pacientes con leucemia se cuantificará la persistencia de enfermedad
mínima residual en médula ósea y sangre periférica mediante técnicas de
citometría multiparamétrica y secuenciación de nueva generación.
- Supervivencia libre de progresión a los 2 años del procedimiento, definida como el
tiempo transcurrido entre la infusión de ARI-0001 y la progresión de la enfermedad o la
muerte. Los pacientes vivos y en remisión completa serán censurados en el momento del
último seguimiento.
- Supervivencia global (SG) a los 2 años, definida como el tiempo transcurrido entre la
infusión de ARI-0001 y el fallecimiento del paciente por cualquier causa. Los pacientes
vivos serán censurados en el momento del último seguimiento.
- Supervivencia in vivo de las células ARI-0001 en sangre periférica, médula ósea y líquido
cefalorraquídeo, lo que se determinará mediante citometría de flujo y PCR cuantitativa
del transgén con periodicidad mensual en los primeros 6 meses y posteriormente
trimestralmente hasta cumplir 2 años de la infusión.
- Calidad de vida de los pacientes incluidos, evaluada mediante un cuestionario que
cumplimentarán los pacientes o sus tutores legales a los 3 y 6 meses y al año.
- Evaluación de la toxicidad a los 3 meses y al año, definida como número de
acontecimientos adversos de cualquier tipo ocurridos a lo largo del estudio empleando
los CTC (common toxicity criteria) versión 3.0.

E.5.2.1

Timepoint(s) of evaluation of this end point

month 3, month 6, 1 year, 2 years and 3 years

mes 3, mes 6, 1 año, 2 años y 3 años

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

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)

Yes

E.7.1.1

First administration to humans

Yes

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)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

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

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

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

Última visita último paciente

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

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

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)

Expected normal treatment of the condition

Tratamiento habitual esperado de la enfermedad

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

2017-05-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-02-23

P. End of Trial
P.	End of Trial Status	Ongoing

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