Clinical Trials Register

Summary
EudraCT Number:	2016-003838-24
Sponsor's Protocol Code Number:	GEMCAD-1602
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:	2017-07-31
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2016-003838-24

A.3

Full title of the trial

A single arm Phase I-II multicenter trial with avelumab plus autologous dendritic cell vaccine in pre-treated mismatch repair-proficient (MSS) metastatic colorectal cancer patients.

Ensayo Clínico fase I-II multicéntrico y no controlado de Avelumab más vacunas autólogas de células dendríticas en pacientes con cáncer colorrectal con genes de reparación de emparejamiento funcionales (MSS), previamente tratados.

A.3.1

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

Avelumab Plus Autologous Dendritic Cell Vaccine for patients with Metastatic Colorectal Cancer Patients that have been previously treated.

Avelumab en combinación vacunas autólogas de células dendríticas en pacientes con cáncer colorrectal metastásico previamente tratados.

A.3.2

Name or abbreviated title of the trial where available

AVEVAC

A.4.1

Sponsor's protocol code number

GEMCAD-1602

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03152565

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	Grupo Español Multidisciplinar en Cáncer Digestivo (GEMCAD)
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	MERCK KGaA
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	MFAR Clinical Research
B.5.2	Functional name of contact point	Verónica Roca
B.5.3	Address:
B.5.3.1	Street Address	Calle Sinfonía 28, 2ª Planta nº1
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28054
B.5.3.4	Country	Spain
B.5.6	E-mail	investigacion@mfar.net

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	Bavencio
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck KGaA
D.2.1.2	Country which granted the Marketing Authorisation	United States
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/16/1798
D.3 Description of the IMP
D.3.1	Product name	Avelumab
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AVELUMAB
D.3.9.1	CAS number	1537032-82-8
D.3.9.2	Current sponsor code	Avelumab
D.3.9.3	Other descriptive name	MSB0010718C
D.3.9.4	EV Substance Code	SUB180078
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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	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	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	Autologous Dendritic Cells Vaccine
D.3.2	Product code	ADC
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intradermal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VACUNA Dendríticas + lisado
D.3.9.3	Other descriptive name	AUTOLOGOUS DENDRITIC CELLS LOADED WITH AUTOLOGOUS TUMOR LYSATE
D.3.9.4	EV Substance Code	SUB99905
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1000000
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Yes
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

MSS colorectal adenocarcinoma

Adenocarcinoma colorrectal MSS

E.1.1.1

Medical condition in easily understood language

MSS colorectal adenocarcinoma

Adenocarcinoma colorrectal MSS

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	10052358
E.1.2	Term	Colorectal cancer metastatic
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

Phase I: To determine the recommended phase II dose (RP2D) of avelumab in combination with ADC vaccine in previously treated MSS CRC patients who have progressed at least to 2 chemotherapy lines.
Phase II: To increase the percentage (from 20% to 40%) of pre-treated MSS mCRC patients free of progression at 6 months.

Fase I: Determinar la dosis recomendada para la fase II (RP2D) de Avelumab en combinación con la vacuna de ACD, en pacientes con CCR MSS previamente tratados y que han progresado al menos a 2 líneas de quimioterapia.
Fase II: Incrementar el porcentaje de pacientes con cáncer colorrectal metastásico con genes de reparación de emparejamiento funcionales (MSS) pretratados, libres de progresión a los 6 meses del 20% a 40% .

E.2.2

Secondary objectives of the trial

1. To evaluate the safety and tolerability of avelumab in combination with ADC vaccine.
2. To identify a favourable phenotype for efficacy.
3. To evaluate pharmacodynamic changes between pre-treatment and on treatment tumour biopsies.
3.1 Modified CMS classification by NanoString.
3.2 Immunophenotype signature by NanoString.

1. Evaluar la seguridad y tolerabilidad de Avelumab en combinación con la vacuna de ACD.
2. Identificar un fenotipo favorable para eficacia.
3. Evaluar los cambios farmacodinámicos en biopsias de tumores pre-tratamiento y durante el tratamiento.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

A translational sub-study will be carried in order to identify a more favourable phenotype for efficacy and to evaluate changes in the phenotype after therapy.

Se llevará a cabo un subestudio con el fin de identificar un fenotipo más favorable para la eficacia y evaluar los cambios en el fenotipo después de la terapia.

E.3

Principal inclusion criteria

- Written informed consent of approved by the investigator’s Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to the performance of any trial activities.
- Histological diagnosis of MSS colorectal adenocarcinoma.
- Metastatic disease treated with at least two chemotherapy line, with or without targeted therapies.
- Male or female subjects aged ≥ 18 years.
- ECOG performance status 0 or 1.
- Measurable disease by RECIST.1.1 criteria.
- LDH levels <1.5 ULN (ULN=450 U/L). Maximum allowed 675 U/L.
- Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normality (ULN) and AST and ALT levels ≤ 2.5 × ULN or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver).
- Negative serum pregnancy test at screening for women of childbearing potential.
- Highly effective contraception for both male and female subjects throughout the study and for at least 30 days after last avelumab treatment administration if the risk of conception exists.
- Adequate hematological function: Haemoglobin ≥ 9 g/dL (may have been transfused). Platelet count ≥ 100 × 109/L. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.
- Renal: Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).

- Firma de consentimiento informado aprobado por el CEIm, antes de la realización de cualquier actividad del ensayo.
- Diagnóstico histológico de adenocarcinoma colorrectal MSS.
- Enfermedad metastásica tratada con al menos dos líneas de quimioterapia, con o sin terapias dirigidas.
- Los sujetos masculinos o femeninos de edades ≥ 18 años.
- Estado funcional ECOG 0 o 1.
- Enfermedad medible según los criterios de RECIST.1.1.
- Niveles de LDH <1,5 veces el LSN (LSN= 450 U/L). Máximo permitido de 675 U/L.
- Función hepática adecuada definida por un nivel de bilirrubina total ≤ x1,5 respecto al límite superior del rango normal (LSN), niveles de AST y ALT ≤ x2,5 LSN o niveles de AST y ALT ≤ 5 x LSN (para sujetos con enfermedad metastásica hepática documentada).
- Prueba de embarazo negativa en suero en las mujeres en edad fértil.
- Anticonceptivo altamente eficaz tanto para los sujetos masculinos y femeninos durante todo el estudio y durante al menos 30 días después de la última administración del tratamiento Avelumab, si existe el riesgo de concepción.
- Función hematológica adecuada:
Hemoglobina ≥ 9 g/dL (puede haber sido transfundido).
Recuento de plaquetas ≥ 100 x 109/L.
Recuento absoluto de neutrófilos (RAN) ≥ 1,5 x 109/L.
- Renal: Aclaramiento de creatinina estimada ≥ 30 ml/min, según fórmula de Cockcroft-Gault (o método local estandarizado).

E.4

Principal exclusion criteria

1. Subjects with brain metastases.
2. Prior organ transplantation, including allogeneic stem-cell transplantation.
3. Presence of clinical ascites.
4. Modified Charlson score >2 (excluded cancer).
5. Significant acute or chronic infections including, among others:
a) Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
b) Positive test for HBV surface antigen and / or confirmatory HCV RNA (if anti-HCV antibody tested positive).
6. Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:
a) Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
b) Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses ≤ 10 mg/24 h of prednisone or equivalent.
c) Administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intraocular, or inhalation) are acceptable.
7. Local positive serologic determination to: HBsAg, Anti-HBc, HBV, HCV, HCV RNA, HIV-I RNA, Agp24 IIIV + AC IIIV ½ (MLIA) serum, IgG antigen core v. hepatitis B, RPR (Ac reagínicos Lues-RPR, serum), IgG cytomegalovirus (EIA), Ac anti HTLV I/II (if patient came from endemic zone), Ac anti Trypanosoma Cruzi, Chagas, (if patient came from endemic zone), when RPR positive or doubtful for confirmation: IgG T. pallidum (ELISA) IgM T pallidum (ELISA) , when IgG T. Pallidum doubtful: Pt confirmatory IgG/IGM, T pallidum (LIA).
8. Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI-CTCAE v 4.03), any history of anaphylaxis, or uncontrolled asthma.
9. Persisting toxicity related to prior therapy of Grade >1 NCI-CTCAE v 4.03; however, alopecia and sensory neuropathy Grade ≤ 2 is acceptable.
10. Pregnancy or lactation.
11. Known alcohol or drug abuse.
12. All other significant diseases (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the Investigator, might impair the subject’s tolerance of trial treatment.
13. Any psychiatric condition that would impede the understanding of informed consent.
14. Vaccination other than study treatment is prohibited, within 4 weeks of the first dose of avelumab and while on trial.
15. History of other tumors in the past 5 years.
16. Active infections.
17. Current immunosuppressive treatment, EXCEPT for the following: a) Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b) Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c) Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
18. Known hypersensitivity to avelumab, ADC vaccines or their components.
19. Legal incapacity or limited legal capacity (patients with legal representative can be enrolled in the trial).
20. Patients with pneumonitis and pulmonary fibrosis
21. Patients with cardiac medical history: CARDIOVASCULAR DISEASE:
“Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.”

1. Pacientes con metástasis cerebrales.
2. Trasplantes previos, incluido el de órganos y trasplante alogénico de células madre.
3. Presencia de ascitis clínica.
4. Escala modificada de Charlson> 2 (cáncer excluido).
5. Infecciones agudas o crónicas significativas incluyendo, entre otros:
a) Historia conocida de prueba positiva para el virus de la inmunodeficiencia humana (VIH) o síndrome de inmunodeficiencia adquirida conocido (SIDA).
b)Antígeno de superficie de Hepatitis B positivo y/o de ARN del VHC confirmatorio (si el anticuerpo anti-hepatitis C es positivo).
6. Enfermedad autoinmune activa que podría deteriorarse cuando se administre un agente inmunoestimulador:
a) Sujetos con diabetes tipo I, vitíligo, psoriasis, hipo o hipertiroidismo que no requieren tratamiento inmunosupresor son elegibles.
b) Sujetos que requieren reemplazo hormonal con corticosteroides son elegibles si los estos se administran sólo con el propósito de reemplazo hormonal y en dosis ≤ 10 mg/24 horas de prednisona o equivalente.
c) Se acepta la administración de esteroides por una vía que genere en una exposición sistémica mínima (tópica, intranasal, intraocular, o inhalación).
7. Determinación serológica positiva local a: HBsAg, Anti-HBc, HBV, HCV, ARN de VHC, ARN de VIH-I, Agp24 IIIV + suero de AC IIIV ½ (MLIA), núcleo de antígeno de IgG contra hepatitis B, RPR (Ac reagínicos Lues -RPR, suero), IgG citomegalovirus (EIA), Ac anti HTLV I / II (si el paciente procede de zona endémica), Ac anti Trypanosoma Cruzi, Chagas, si RPR positivo o dudoso para confirmación: IgG T. pallidum (ELISA) IgM T pallidum (ELISA), cuando IgG T. Pallidum dudosa: Pt confirmatoria IgG / IGM, T pallidum (LIA).
8. Reacciones de hipersensibilidad graves conocidas a anticuerpos monoclonales (Grado ≥ 3 NCI-CTCAE v 4.03), cualquier antecedente de anafilaxia o asma no controlada.
9. Toxicidad persistente relacionada con el tratamiento previo de Grado> 1 NCI-CTCAE v 4.03. Sin embargo, se permite alopecia y neuropatía sensorial de grado ≤ 2.
10. Embarazo o lactancia.
11. Abuso conocido de alcohol o drogas.
12. Cualquier otra enfermedad significativa que en opinión del investigador, podría alterar la tolerancia del sujeto al tratamiento del estudio (por ejemplo, enfermedad inflamatoria intestinal, asma no controlado).
13. Cualquier condición psiquiátrica que dificulte la comprensión del consentimiento informado.
14. El tratamiento con vacunas diferentes a las del estudio está prohibido, dentro de las 4 semanas previas de la primera dosis de Avelumab y durante el ensayo.
15. Antecedentes de otros tumores en los últimos 5 años.
16. Infección activa.
17. Tratamiento inmunosupresor actual, con excepción de lo siguiente:
a) Esteroides intranasales, tópicos inhalados, o inyección local de esteroides (por ejemplo, inyección intra-articular);
b) Los corticosteroides sistémicos a dosis fisiológicas ≤ 10 mg/día de prednisona o equivalente;
c) Esteroides como premedicación para las reacciones de hipersensibilidad (por ejemplo, premedicación para TC).
18. Hipersensibilidad conocida a Avelumab, vacunas ACD o sus componentes.
19. Incapacidad legal y la capacidad legal limitada (se pueden incluir pacientes con representante legal).
20. Pacientes con neumonitis y fibrosis pulmonar.
21. Pacientes con antecedentes de enfermedad cardiovascular clínicamente significativa (activa), incluyendo accidente cerebrovascular/isquemia cerebral (<6 meses antes de la inclusión), infarto de miocardio (<6 meses antes de la inclusión), angina inestable, insuficiencia cardíaca congestiva (Clasificación New York Heart Association ≥ Clase II), o arritmia cardiaca grave que requiera de tratamiento farmacológico.

E.5 End points

E.5.1

Primary end point(s)

Phase I: recommended phase II dose (RP2D) of avelumab in combination with ADC vaccine in previously treated MSS CRC patients who have progressed at least to 2 chemotherapy lines.

Phase II: To increase the percentage (from 20% to 40%) of pre-treated MSS mCRC patients free of progression at 6 months.

Fase I: Determinar la dosis recomendada para la fase II (RP2D) de Avelumab en combinación con la vacuna de ACD, en pacientes con CCR MSS previamente tratados y que han progresado al menos a 2 líneas de quimioterapia.

Fase II: Incrementar el porcentaje de pacientes con cáncer colorrectal metastásico con genes de reparación de emparejamiento funcionales (MSS) pretratados, libres de progresión a los 6 meses del 20% a 40% .

E.5.1.1

Timepoint(s) of evaluation of this end point

Phase I: 1rst cycle
Phase II: 6 months

Fase I: primer ciclo
Fase II: 6 meses

E.5.2

Secondary end point(s)

- Evaluar la seguridad y tolerabilidad de Avelumab en combinación con la vacuna de ACD.
- Identificar un fenotipo favorable para eficacia.
- Evaluar los cambios farmacodinámicos en biopsias de tumores pre-tratamiento y durante el tratamiento.

E.5.2.1

Timepoint(s) of evaluation of this end point

18 months

18 meses

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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

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

Dose feasibilty in 3+3 modified phase I trial

Factibilidad de dosis en modelo de fase I 3+3 modificado

E.7.2

Therapeutic exploratory (Phase II)

Yes

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

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

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

End of study has been defined as the Last Visit of the Last Patient (LVLP)

Fin del estudio se ha definido como la última visita del último paciente (LVLP)

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

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Patients with legal representative can be enrolled in the trial.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

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)

Standard treatment according patient's clinical condition.

Tratamiento habitual previsto para la situación clínica del paciente.

G. Investigator Networks to be involved in the Trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-03-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-01-18

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials