Clinical Trials Register

Summary
EudraCT Number:	2020-004838-37
Sponsor's Protocol Code Number:	AloCELYVIR
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:	2022-07-11
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

Spain - AEMPS

A.2

EudraCT number

2020-004838-37

A.3

Full title of the trial

Phase IB clinical trial to assess the safety, tolerability, and preliminary efficacy of AloCELYVIR (Mesenchymal allogenic cells + ICOVIR-5) in children, adolescent and young adults with newly diagnosed diffuse intrinsic pointine glioma (DIPG) in combination with radiotherapy or medulloblastoma in relapse/progression in monotherapy.

Ensayo clínico Fase Ib para evaluar la seguridad, tolerabilidad y la eficacia de AloCELYVIR (células mesénquimales alogénicas + Icovir-5) en niños adolescentes y adultos jóvenes con glioma difuso de la protuberancia (DIPG) de nuevo diagnóstico en combinación con radioterapia o meduloblastoma en recaída/ progresión en monoterapia

A.3.1

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

Phase IB clinical trial to assess the safety, tolerability, and preliminary efficacy of AloCELYVIR in children, adolescent and young adults with diffuse intrinsic pointine glioma (DIPG) or medulloblastoma.

Ensayo clínico Fase Ib para evaluar la seguridad, tolerabilidad y la eficacia de AloCELYVIR en niños, adolescentes y adultos jóvenes con glioma difuso de la protuberancia (DIPG) o meduloblastoma.

A.3.2

Name or abbreviated title of the trial where available

FIBHNJ-2020-01

A.4.1

Sponsor's protocol code number

AloCELYVIR

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	Fundación de Investigación Biomédica Hospital Niño Jesús
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	Fundación Cris Contra el Cáncer
B.4.2	Country	Spain
B.4.1	Name of organisation providing support	Fundación el Sueño de Vicky
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	APICES SOLUCIONES S.L
B.5.2	Functional name of contact point	Clinical Operations Department
B.5.3	Address:
B.5.3.1	Street Address	Avenida Antonio López 16, 1ºA
B.5.3.2	Town/ city	Pinto, Madrid
B.5.3.3	Post code	28320
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34918166804100
B.5.6	E-mail	ana.moreno@apices.es

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	ALOCELYVIR
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Alogenic bone marrow stem adult mesenchymal cells expanded Infected with Icovir-5
D.3.9.2	Current sponsor code	ICOVIR-5
D.3.9.3	Other descriptive name	ADENOVIRUS TYPE 5 VECTOR
D.3.9.4	EV Substance Code	SUB196201
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500000
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	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Newly diagnosed Diffuse Intrinsic Pointine Glioma (DIPG) or Medulloblastoma in relapse/progression in children, adolescents and young adults.

Glioma difuso de la protuberancia (DIPG) de nuevo diagnóstico y meduloblastoma en recaída/progresión en niños, adolescentes y adultos jóvenes.

E.1.1.1

Medical condition in easily understood language

Glioma and medulloblastoma in children, adolescents and young adults.

Glioma y meduloblastoma en niños, adolescentes y adultos jóvenes.

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	21.0
E.1.2	Level	PT
E.1.2	Classification code	10066594
E.1.2	Term	Medulloblastoma recurrent
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	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10080666
E.1.2	Term	Diffuse intrinsic pontine glioma
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

1. To evaluate the safety of the combination of AloCelyvir and radiotherapy in patients with newly diagnosed DIPG.

2. To evaluate the safety of AloCelyvir in monotherapy in patients with progression/relapse in medulloblastoma.

1. Evaluar la seguridad de la combinación de AloCelyvir sumado a la radioterapia en pacientes con nuevo diagnóstico de DIPG.

2. Evaluar la seguridad de AloCelyvir en monoterapia en pacientes con progresión/recaída en meduloblastoma.

E.2.2

Secondary objectives of the trial

1. Measurement of antitumor activity (measured as objective response rate [complete response and partial response] of the combination/monotherapy)
2. Feasibility of the combination/monotherapy
3. Safety (expansion phase)
4. Estimation of progression-free survival (PFS)
5. Estimation of overall survival (OS)
6. To compare the progression-free survival and overall survival of cohort A and B with a historical cohort of newly diagnosed DIPG patients and with a historical cohort of patients with relapse medulloblastoma.
7. To study the antiadenoviral immune response in patients
8. To Study the replication kinetics of Icovir-5

1. Medida de la actividad antitumoral (medida como tasa de respuesta objetiva [respuesta completa y respuesta parcial] de la combinación/monoterapia)
2. Viabilidad de la combinación/monoterapia
3. Seguridad (fase de expansión)
4. Estimación de la supervivencia libre de progresión
5. Estimación de la supervivencia global
6. Comparar la supervivencia libre de progresión y global de las cohortes A y B con una cohorte histórica de pacientes con DIPG de nuevo diagnóstico y una cohorte de pacientes con meduloblastoma en recaída/progresión.
7. Estudiar la respuesta inmune antiadenoviral en los pacientes.
8. Estudiar la cinética de replicación de Icovir-5.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

INCLUSION CRITERIA COMMON TO THE TWO COHORTS

1. Patients aged 1 to 21 years.
2. Written informed consent signed by the patient's legal representative and, if applicable, the minor (informed consent in patients 12 years of age or older).
3. Measurable or evaluable disease according to RANO criteria.
4. Appropriate functional status, organic function (renal, hepatic) and hematological values:
o Lanksy and karnofsky functional status ≥50%. Patients who use a wheelchair due of tumor-associated paralysis will be considered as outpatients for functional status evaluation.
o Haematology function:
• Platelet count ≥75.000/µL (without support for 3 days)
• Absolute neutrophil count (ANC) ≥500/ µL (without growth factor for 3 days)
• Hemoglobin ≥ 8 g/dL (Transfusion allowed)
o Liver and renal function
• Glomerular filtration rate (GFR) (estimated by Schwartz ) >60 mL/min/1.73 m2
• Total bilirubin ≤ 1.5 × the upper limit of normal (ULN)
• Transaminases (GOT and GPT) ≤3 × the upper limit of normal (ULN). ≤ 5 times ULN for patients with hepatic metastasis.
5. Patient able to comply with treatment and schedule of visits and assessments
6. Life expectancy of ≥8 weeks.
7. Highly effective contraceptive methods (Pearl rate <1) for sexually active males and females of childbearing age (CTFG, Reccomendations related to contraception and pregnancy in clinical trials V 1.1 2020--15). A woman is considered to have reproductive potential, i.e., childbearing, when she has reached menarche through menopause, unless she is permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy
8. Highly sensitive negative pregnancy test in blood or urine for childbearing females.

INCLUSION CRITERIA COMMON TO THE COHORT A

1. Patient with new DIPG diagnosis (clinical, radiological, or histological in case a biopsy was performed before being included in the study).
2. Not having received previous treatment with radiotherapy or chemotherapy.
3. Patient able to receive radiotherapy

INCLUSION CRITERIA COMMON TO THE COHORT B

1. Patient diagnosed with relapsed and/or refractory medulloblastoma. Patients must have received at least surgery, radiation therapy and chemotherapy as part of standard treatment and have failed these treatments before they can participate in this study.
2. To be recovered to ≤ G1 from the toxic effects according to CTCAE derived from the previous treatments, excluding ototoxicity, alopecia and peripheral neurotoxicity.

CRITERIOS DE INCLUSION COMUNES A LAS DOS COHORTES:

1. Pacientes con edades comprendidas entre 1 año y ≤ 21 años.
2. Consentimiento informado por escrito y firmado por el representante legal del paciente y, si procede, del menor (asentimiento informado en pacientes de 12 años o más).
3. Enfermedad medible o evaluable según criterios RANO31-33.
4. Adecuados estado funcional, función orgánica (renal, hepática) y valores hematológicos:
o Estado funcional de Lansky ≥50% y de Karnofsky ≥50%. Los pacientes que utilizan silla de ruedas por parálisis asociada al tumor se considerarán ambulatorios para la evaluación del estado funcional.
o Función hematológica
• Plaquetas ≥75.000/µL (sin soporte durante 3 días)
• Neutrófilos totales ≥500/ µL (sin factor de crecimiento durante 3 días)
• Hemoglobina ≥ 8 g/dL (transfusiones permitidas)
o Función renal y hepática
• Filtrado glomerular (estimada por Schwartz) >60 ml/min/1,73 m2.
• Bilirrubina total ≤1,5 veces el valor alto de la normalidad.
• Transaminasas (GOT y GPT) ≤3 veces el valor alto de la normalidad. En caso de pacientes con metástasis hepáticas ≤5 veces el valor alto de la normalidad
5. Paciente capaz de cumplir con el tratamiento y plan de visitas y evaluaciones.
6. Expectativa de vida ≥8 semanas.
7. Métodos anticonceptivos altamente eficaces (índice Pearl <1) para los varones sexualmente activos y las mujeres en edad fértil.(CTFG, Indicaciones relacionadas con la contracepción y el embarazo en ensayos clínicos V 1.1 2020--15). Una mujer se considera con capacidad reproductiva, es decir, fértil, aquella que ha alcanzado la menarquia y hasta la menopausia, a menos que sea estéril de forma permanente. Los métodos de esterilización permanente incluyen histerectomía, salpingectomía bilateral y ooforectomía bilateral.
8. Test de embarazo altamente sensible negativo en sangre u orina para las mujeres fértiles.

CRITERIOS DE INCLUSION ESPECÍFICOS COHORTE A:

1. Paciente con nuevo diagnóstico de DIPG (clínico, radiológico, o histológico en caso de que se le haya practicado una biopsia antes de ser incluido en el estudio)
2. No haber recibido tratamiento previo con radioterapia o quimioterapia
3. Paciente capaz de recibir radioterapia

CRITERIOS DE INCLUSION ESPECÍFICOS COHORTE B:

1. Paciente con diagnóstico de meduloblastoma en recaída y/o refractario. Los pacientes deben haber recibido como parte del tratamiento estándar al menos cirugía, radioterapia y quimioterapia y haber fracasado estos tratamientos antes de poder participar en este estudio.
2. Estar recuperado a ≤ G1 de los efectos tóxicos según CTCAE derivados de los tratamientos previos, excluyendo ototoxidad, alopecia y neurotoxicidad periférica.

E.4

Principal exclusion criteria

EXCLUSION CRITERIA COMMON TO THE TWO COHORTS

1. Previous treatment with Celyvir or AloCelyvir.
2. Known active bacterial, viral, fungal or parasitic infection not controlled
3. Known active Hepatitis B or C virus or VIH infection.
4. If patients are treated with corticosteroids, they should be clinically stable and on stable or tapering doses of steroids for at least one week.
5. To be receiving another anti-cancer treatment not foreseen in this protocol or to anticipate receiving it during the patient's participation in the same concomitant with the experimental treatment
6. Clinically significant or uncontrolled serious active and past systemic diseases that may pose an added risk to the patient

EXCLUSION CRITERIA COMMON TO THE COHORT A

1. Spontaneous massive intratumoral bleeding. Patients with post-operative bleeding (in case of biopsy or surgery) may be included in the study provided that the bleeding is controlled. The same rule applies for other postoperative complications (infection, loss of cerebrospinal fluid, absence of wound closure, subdural collection ...)
2. Patients who have previously received radiotherapy to the brain stem for another malignancy

EXCLUSION CRITERIA COMMON TO THE COHORT B

1. Washout period respect to previous treatments:
- At least two weeks since the last dose of chemotherapy. For patients receiving low-dose metronomic oral chemotherapy, this period is at least one week.
- At least four weeks since the autologous hematopoietic stem cell transplant
- At least two weeks since the last focal radiotherapy or six weeks in case of cranio-spinal radiotherapy.
- At least 2 weeks or 5 half-lifes (whichever occurs first) since the last dose of a biological or investigational treatment.

CRITERIOS DE EXCLUSION COMUNES A LAS DOS COHORTES:

1. Tratamiento previo con Celyvir o AloCelyvir
2. Infección activa conocida bacteriana, viral, fúngica o parasitaria conocida no controlada
3. Infección activa conocida por virus de hepatitis B o C o VIH
4. Si los pacientes reciben tratamiento con corticoides, deberán estar clínicamente estables y con dosis de esteroides estables o en descenso durante al menos una semana
5. Estar recibiendo otro tratamiento anticanceroso no previsto en este protocolo o prever que lo vaya a recibir durante la participación del paciente en el mismo concomitantemente con el tratamiento experimental
6. Enfermedades sistémicas activas y pasadas graves clínicamente significativas o no controladas que puedan implicar un riesgo añadido para el paciente

CRITERIOS DE EXCLUSIÓN ESPECÍFICOS COHORTE A:

1. Sangrado espontáneo masivo intratumoral. Los pacientes con sangrado postoperatorio (en caso de biopsia o cirugía) podrán ser incluidos en el estudio siempre que se controle la hemorragia. La misma regla se aplica para las otras complicaciones postoperatorias (infección, pérdida de líquido cefalorraquídeo, ausencia de cierre de la herida, colección subdural ...)
2. Pacientes que hayan recibido previamente radioterapia en el tronco cerebral por otra neoplasia

CRITERIOS DE EXCLUSIÓN ESPECÍFICOS COHORTE B:

1. Periodos de lavado respecto a tratamientos previos
- Al menos dos semanas de la última dosis de quimioterapia. Para pacientes recibiendo quimioterapia oral metrónomica a bajas dosis, este periodo es de al menos una semana.
- Al menos cuatro semanas desde el trasplante autólogo de progenitores hematopoyéticos
- Al menos dos semanas desde la última radioterapia focal o seis semanas en caso de radioterapia craneoespinal
- Al menos dos semanas o 5 vidas medias (el que ocurra antes) desde la última dosis de un tratamiento biológico o investigacional

E.5 End points

E.5.1

Primary end point(s)

1. Dose-Limiting Toxicities rate (DLTs)

1. Tasa de toxicidades limitantes de dosis

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Every week during 4 weeks.

1. Cada semana durante 4 semanas

E.5.2

Secondary end point(s)

1. Objective response rate
2. Rate of patients meeting selection criteria who can receive at least one cycle of Alo-Celyvir
3. Progression-free survival (PFS)
4. Overall survival
5. To compare the progression-free survival and overall survival of cohort A and B with a historical cohort of newly diagnosed DIPG patients and with a historical cohort of patients with relapse medulloblastoma
6. Adverse Events Rate
7. Kinetics of anti-Adenovirus serotype 5 antibody titers
8. Kinetics of the number of CD8 antiadenovirus T-lymphocytes
9. Kinetics of circulating adenoviral particles

1. Tasa de respuesta objetiva
2. Tasa de pacientes que cumplen criterios de selección que pueden recibir al menos un ciclo de Alocelyvir
3. Supervivencia libre de progresión
4. Supervivencia global
5. Comparación de la supervivencia libre de progresión y global de las cohortes A y B con una cohorte de pacientes con DIPG de nuevo diagnóstico y una cohorte de pacientes con meduloblastoma en recaída.
6. Tasa de acontecimientos adversos
7. Cinética de títulos de anticuerpos antiadenovirus serotipo 5
8. Cinética del número de linfocitos T CD8 antiadenovirus
9.Cinética de partículas adenovirales circulantes

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Every 12 weeks since the start of treatment until disease progression.
2. Since the start of recruitment until the first dose of AloCelyvir.
3. Every 12 weeks since the start of treatment until disease progression.
4. Every 12 weeks since the start of treatment until death.
5. Every 12 weeks since the start of treatment until disease progression.
6. Every week during 8 weeks and at week 10 of study treatment.
7. Every week during 8 weeks and at week 10 of study treatment.
8. Every week during 8 weeks and at week 10 of study treatment.
9. Every week during 8 weeks and at week 10 of study treatment.

1. Cada 12 semanas desde el inicio del tratamiento hasta progresión de la enfermedad.
2. Desde el inicio del reclutamiento hasta la primera dosis de Alocelyvir
3. Cada 12 semanas desde el inicio del tratamiento hasta progresión de la enfermedad.
4. Cada 12 semanas desde el inicio del tratamiento hasta fallecimiento.
5. Cada 12 semanas desde el inicio del tratamiento hasta progresión de la enfermedad.
6. Cada semana durante 8 semanas y en la semana 10 del tratamiento del estudio.
7. Cada semana durante 8 semanas y en la semana 10 del tratamiento del estudio.
8. Cada semana durante 8 semanas y en la semana 10 del tratamiento del estudio.
9. Cada semana durante 8 semanas y en la semana 10 del tratamiento del estudio.

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

Yes

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

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Safety Phase IB study

Estudio de seguridad fase IB .

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.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

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) Last visit last patient

(LVLS) Última visita del 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

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

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

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)

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

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

An inclusion criteria is "Patients aged between 1 year and ≤21 years"

Un criterio de inclusión es "Pacientes con edades comprendidas entre 1 año y ≤ 21 años"

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)

Follow up of patientes included in the study

Seguimiento de los pacientes incluidos en el estudio

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

2021-04-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-02-23

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

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