Clinical Trials Register

Summary
EudraCT Number:	2018-002094-22
Sponsor's Protocol Code Number:	FiHM006
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:	2019-01-18
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

2018-002094-22

A.3

Full title of the trial

A Phase II Trial to Assess the Evolution of KRAS Mutation Load by Liquid Biopsy in Patients with Resectable Pancreatic Ductal Adenocarcinoma Treated with Neoadjuvant NALIRINOX

Ensayo fase II para evaluar la evolución de la carga de mutación de KRAS por biopsia
líquida en pacientes con adenocarcinoma ductal pancreático resecable tratados con
tratamiento neoadyuvante NALIRINOX

A.3.1

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

A study to investigate changes in the amount of mutations in patients with Resectable Pancreatic Ductal Adenocarcinoma

Un estudio para investigar cambios en la cantidad de mutaciones en pacientes con adenocarcinoma ductal pancreático

A.3.2

Name or abbreviated title of the trial where available

Nalirinox neo-pancreas RAS mut ctDNA study

Estudio ctDNA mut RAS neopancreas Nalirinox

A.4.1

Sponsor's protocol code number

FiHM006

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 de HM Hospitales
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 de investigación de HM Hospitales
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	Fundación de investigación de HM Hospitales
B.5.2	Functional name of contact point	Secretaría
B.5.3	Address:
B.5.3.1	Street Address	Plaza Conde Valle de Suchil, 2
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28015
B.5.3.4	Country	Spain
B.5.4	Telephone number	+3491 756 79 84
B.5.6	E-mail	secretaria@fundacionhm.com

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	ONIVYDE 5 mg/ml concentrado para solución para perfusión
D.2.1.1.2	Name of the Marketing Authorisation holder	Baxalta Innovations GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	irinotecan liposome injection
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	Intrauterine use Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IRINOTECAN
D.3.9.1	CAS number	97682-44-5
D.3.9.4	EV Substance Code	SUB08295MIG
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	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.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	Oxaliplatino Teva 5 mg/ml concentrado para solución para perfusión EFG
D.2.1.1.2	Name of the Marketing Authorisation holder	Teva Pharma S.L.U.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	oxaliplatin
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 Implantation
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	OXALIPLATIN
D.3.9.1	CAS number	61825-94-3
D.3.9.4	EV Substance Code	SUB09490MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/l milligram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
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	Folinato cálcico Teva 10 mg/ml solución inyectable EFG
D.2.1.1.2	Name of the Marketing Authorisation holder	Teva Pharma S.L.U.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Leucovorin
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Leucovorin
D.3.9.1	CAS number	68538-85-2
D.3.9.3	Other descriptive name	LEVOLEUCOVORIN
D.3.9.4	EV Substance Code	SUB34736
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	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.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	Fluorouracilo Accord 50 mg/ml solución inyectable o para perfusión EFG
D.2.1.1.2	Name of the Marketing Authorisation holder	Accord Healthcare S.L.U.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Leucovorin
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	5-FU
D.3.9.3	Other descriptive name	FLUOROURACIL
D.3.9.4	EV Substance Code	SUB07721MIG
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	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Resectable Pancreatic Ductal Adenocarcinoma

Adenocarcinoma ductal pancreático resecable

E.1.1.1

Medical condition in easily understood language

pancreatic cancer that can have surgery

cáncer de páncreas susceptible de ser operado

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	LLT
E.1.2	Classification code	10033602
E.1.2	Term	Pancreatic adenocarcinoma resectable
E.1.2	System Organ Class	100000004864

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 evaluate the association of KRAS mutational load and histological tumor response after chemotherapy treatment in patients with PDAC. The histopathological outcome in surgical specimens will be correlated with KRAS mutational load detected in cfDNA of blood by BEAMing

Evaluar la asociación de la carga mutacional de KRAS y la respuesta tumoral histológica después del tratamiento con quimioterapia en pacientes con PDAC. El resultado histopatológico en muestras quirúrgicas se correlacionará con la carga mutacional de KRAS detectada en cfDNA de sangre por BEAMing.

E.2.2

Secondary objectives of the trial

- To evaluate the association of overall survival and KRAS mutational load after surgery in plasma from patients with PDAC.
-To evaluate the association of progression-free survival and KRAS mutational load after surgery in plasma from patients with PDAC.
-To evaluate the association of R0 resection rate and KRAS mutational load before surgery in plasma from patients with PDAC.
- To evaluate the safety profile of NALIRINOX by recording the incidence of AEs. Acute and late toxicity of NALIRINOX treatment will be evaluated according to the Common Toxicity Criteria (CTC) for adverse events (AE).
- To evaluate the efficacy of NALIRINOX in terms of overall survival and one-year survival.

- Evaluar la asociación de la supervivencia general y la carga mutacional de KRAS después de la cirugía en plasma de pacientes con PDAC.
- Evaluar la asociación de la supervivencia libre de progresión y la carga mutacional de KRAS después de la cirugía en plasma de pacientes con PDAC.
- Evaluar la asociación de la tasa de resección R0 y la carga mutacional de KRAS antes de la cirugía en plasma de pacientes con PDAC.
- Evaluar el perfil de seguridad de NALIRINOX registrando la incidencia de eventos adversos.
La toxicidad aguda y tardía del tratamiento con NALIRINOX se evaluará de acuerdo con los Criterios de Toxicidad Comunes (CTC) para los eventos adversos (EA).
- Evaluar la eficacia de NALIRINOX en términos de supervivencia global y supervivencia a un año.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or females, aged 18 years or older
2. Histologically or cytologically confirmed diagnosis of PDAC
3. Candidates for pancreatic cancer surgery (no cormobidities that can exclude for surgery)
4. Life expectance of at least 12 months
5. Carbohydrate antigen 19-9 (CA19-9) levels < 500 U/ml
6. ECOG performance status < or 1
7. Adequate bone marrow function
8. Adequate hepatic function
9. Adequate renal function
10. Sexually active men and women of childbearing potential must use efficient contraceptive methods. Contraceptive methods comprise: oral contraceptives, intrauterine devices, sexual abstinence, tubal ligation, IUD, barrier methods or another contraceptive considered appropriate by the investigator. Women of childbearing potential must have a negative serum pregnancy test before study entry.
11. Agree to participate and signed the ICF.

1. Hombres o mujeres, de 18 años o más
2. Diagnóstico histológico o citológico confirmado de PDAC
3. Candidatos para cirugía de cáncer de páncreas (sin cormobidades que pueden excluir para la
cirugía)
4. Esperanza de vida de al menos 12 meses
5. Antígeno de carbohidratos 19-9 (CA19-9) niveles <500 U / ml
6. Estado funcional ECOG < o = 1
7. Adecuada function de médula osea
8. Función hepática adecuada
9. Función renal adecuada
10. Los hombres y mujeres sexualmente activos en edad fértil deben usar métodos anticonceptivos eficientes. Los métodos anticonceptivos comprenden: anticonceptivos orales, dispositivos intrauterinos, abstinencia sexual, ligadura de trompas, DIU, métodos de barrera u otro anticonceptivo que el investigador considere apropiado. Las mujeres en edad fértil deben tener una prueba de embarazo en suero negativa antes del ingreso al estudio.
11. Aceptar participar y firmar el document de consentimiento informado.

E.4

Principal exclusion criteria

1. Patients with metastatic disease
2. Patients > or =75 years.
3. Uncontrolled coagulopathy
4. Patients with a contraindication to surgery (locally advanced disease or patients not
amenable to pancreatic surgery due to a previous comorbidity)
5. Patients with prior or concurrent malignant disease that required treatment with
chemotherapy in the past.
6. Previous citotoxic therapy within 36 months for other no-cancer disease (ie arthritis
rheumatoid)
7. Known or suspected reactions to any component of the study medication (5-FU/LV, nal-
IRI or oxaliplatin) or to components of similar chemical or biologic composition
8. Concurrent participation in any other clinical trial likely to interfere with the therapeutic schedule
9. Human immunodeficiency virus (HIV) positivity, active Hepatitis B or Hepatitis C
infection.
10. Uncontrolled illness including ongoing or active infection, symptomatic congestive
heart failure, unstable angina, cardiac arrhythmia, myocardial infarction, or left ventricular
ejection fraction (LVEF) < 50, among others, or psychiatric illness/social situations that
would limit compliance with study requirements.
11. Pregnant or breast-feeding women.
12. Any medical condition that, based on investigator’s criteria, places the subject at risk,
makes the subject ineligible or may jeopardize protocol compliance.

1. Pacientes con enfermedad metastásica
2. Pacientes > o = 75 años.
3. Coagulopatía no controlada
4. Pacientes con una contraindicación para la cirugía (enfermedad localmente avanzada o
pacientes no susceptibles a cirugía pancreática debido a una comorbilidad previa)
5. Pacientes con enfermedad maligna previa o concurrente que requirieron tratamiento con
quimioterapia en el pasado.
6. Terapia antitumoral previa en los 36 meses previos
7. Reacciones conocidas o sospechadas de cualquier componente de la medicación del estudio
(5-FU / LV, nal-IRI u oxaliplatino) o a componentes de composición química o biológica
similar
8. Participación concurrente en cualquier otro ensayo clínico que pueda interferir con el
programa terapéutico
9. Positividad del virus de la inmunodeficiencia humana (VIH), hepatitis B activa o infección
de la hepatitis C.
10. Enfermedad no controlada, incluyendo infección activa o en curso, insuficiencia cardíaca
congestiva sintomática, angina inestable, arritmia cardíaca, infarto de miocardio o fracción de
eyección del ventrículo izquierdo (FEVI) <50, entre otros, o enfermedades psiquiátricas /
situaciones sociales que limitarían el cumplimiento de los requisitos del estudio .
11. Mujeres embarazadas o lactantes.
12. Cualquier condición médica que, de acuerdo con los criterios del investigador, ponga al
sujeto en riesgo, lo haga inelegible o ponga en riesgo el cumplimiento del protocolo.

E.5 End points

E.5.1

Primary end point(s)

Proportion of subjects with a good histological tumour response in the resected specimens after neoadjuvant chemotherapy with NALIRINOX and surgical removal according to the Ryan’s classification in a dichotomic way (0-1: good; 2-3: bad) in KRAS positive and negative patients assessed by liquid biopsy and BEAMing.

Proporción de sujetos con una buena respuesta histológica tumoral en las muestras
resecadas después de la quimioterapia neoadyuvante con NALIRINOX y la
extirpación quirúrgica de acuerdo con la clasSiicación de Ryan de forma dicotómica
(0-1: bueno; 2-3: malo) en pacientes KRAS positivos y negativos evaluados por
biopsia líquida y BEAMing.

E.5.1.1

Timepoint(s) of evaluation of this end point

8 weeks after surgical intervention

8 semanas tras la intervención quirúrgica

E.5.2

Secondary end point(s)

- R0 resection, PFS, 1-year survival and OS in baseline KRAS+ and KRAS- subjects.
- Assessment of the number and proportion of KRAS- subjects switching to KRAS+ (and from KRAS+ to negative) after neoadjuvant NALIRINOX and its impact on R0 resection, histological tumour response, PFS and 1-year survival and OS.
- Description of the safety profile of the neoadjuvant NALIRINOX scheme: AEs, SAEs according to the CTCAE.

- resección R0, PFS, supervivencia a 1 año y SG en sujetos KRAS y KRAS iniciales.
- Evaluación del número y la proporción de sujetos con KRAS que cambian a KRAS
+ (y de KRAS + a negativo) después del neoadyuvante NALIRINOX y su impacto en
la resección R0, la respuesta tumoral histológica, la SLP y la supervivencia a 1 año y
la SG.
- Descripción del perfil de seguridad del esquema neoadyuvante NALIRINOX:
AEs, SAEs según CTCAE.

E.5.2.1

Timepoint(s) of evaluation of this end point

Through the study

A lo largo 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

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)

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.8.2.4

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

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 Subject Last Visit

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

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

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

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.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)

Not applicable - None

No procede - Ninguno

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

2019-01-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-12-21

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

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