Clinical Trials Register

Summary
EudraCT Number:	2018-002095-40
Sponsor's Protocol Code Number:	HM-RE-2017-01
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
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

2018-002095-40

A.3

Full title of the trial

Phase II, multicenter, open-label, non-randomized study of neoadjuvant
chemotherapy NALIRINOX (5-FU/LV + oxaliplatin + nal-IRI) followed by
chemoradiotherapy in patients with rectal cancer in a watch-and-wait program.

Estudio Fase II multicéntrico, abierto, no aleatorizado de quimioterapia neoadyuvante con NALIRINOX (5-FU/LV + oxaliplatino + nal-IRI) seguido de quimiorradioterapia en pacientes con cáncer rectal en programa “watch and wait”

A.3.1

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

A study to evaluate a chemotherapy treatment followed by chemo and radiotherapy in patients with rectal cancer

Un estudio para evaluar un tratamiento quimioterápico y posterior quimio y radioterapia en pacientes con cancer de recto

A.4.1

Sponsor's protocol code number

HM-RE-2017-01

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	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

Rectal cancer

Cáncer de recto

E.1.1.1

Medical condition in easily understood language

rectal cancer

cáncer de recto

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	10038038
E.1.2	Term	Rectal cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of neoadjuvant chemotherapy combination (5FU/LV +
Oxaliplatin + nal-IRI) to determine the percentage of clinical responses after
neoadjuvant treatment in patients with LARC.

Evaluar la eficacia de la combinación de quimioterapia neoadyuvante (5FU / LV +
Oxaliplatino + Nal-IRI) para determinar el porcentaje de respuestas clínicas después
del tratamiento neoadyuvante en pacientes con cáncer rectal local avanzado (CRLA)

E.2.2

Secondary objectives of the trial

- Safety profile of neoadjuvant chemotherapy combination (5FU/LV + Oxaliplatin +
Nal-IRI).
- Efficacy in terms of OS, PFS and assessment of patients that will be able to go on
a “watch-and-wait” strategy

- Perfil de seguridad de la combinación de la quimioterapia neoadyuvante (5FU/LV + Oxaliplatin + Nal-IRI).
- Eficacia en términos de SG (supervivencia global), SLP (supervivencia libre de progression) y evaluación de pacientes que podrán pasar a realizer la estrategia “watch & wait”.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or females, aged > or = 18 years.
2. Agree to participate and sign voluntary written ICF before any study specific
procedure.
3. Patients with confirmed histopathological diagnosis of rectal cancer.
4. Patients with locally advanced rectal cancer T3-T4N0M0 or TxN+M0 and selected T2N0M0 candidates to watch & wait program.
5. Patients considered for neoadjuvant treatment according to usual clinical practice
may also be potential candidates.
6. ECOG performance status 0 or 1.
7. Patients who can receive radiotherapy and chemotherapy.
8. No prior or concurrent malignant disease unless in complete remission for more
than three years, except for adequately treated in situ carcinoma of the cervix, basal
or squamous skin cell carcinoma or in situ transitional bladder cell carcinoma.
9. Women of childbearing potential (WOCBP) must have a negative serum pregnancy
test before study entry. Both women and men must agree to use a highly effective
contraceptive measure throughout the treatment period and for six months after
discontinuation of treatment.
10. Adequate hematologic function
11. Adequate hepatic function
12. Adequate renal function
13. No peripheral neuropathy (< Grade 2)
14. No known history of dihydropyrimidine dehydrogenase deficiency (DPD)

1. Hombres o mujeres, de edad > o = 18 años.
2. Aceptar participar y firmar voluntariamente el ICF por escrito antes de realizar cualquier
procedimiento específico del estudio.
3. Pacientes con diagnóstico histopatológico confirmado de cáncer rectal.
4. Pacientes con cancer rectal local avanzado T3-T4N0M0 o TxN+M0 i T2N0M0 seleccionados
candidatos para programa de “watch & wait“
5. Los pacientes que son considerados para tratamiento neoadyuvante de acuerdo con la práctica
clínica habitual también pueden ser candidatos potenciales para este estudio.
6. ECOG 0 o 1.
7. Pacientes que pueden recibir radioterapia y quimioterapia.
8. Ausencia de enfermedad maligna previa oactual, a menos que esté en remisión completa desde
hace más de tres años. Excepción para carcinoma in situ del cuello uterino, el carcinoma de
células cutáneas basales o escamosas o el carcinoma in situ de células transicionales de la vejiga
adecuadamente tratados. .
9. Las mujeres en edad fértil deben tener una prueba de embarazo en suero negativa antes
de su inclusión en elestudio. Tanto las mujeres como los hombres deben aceptar utilizar
un método anticonceptivo altamente efectivo durante todo el período de tratamiento y
durante seis meses después de la suspensióndel tratamiento.
10. Función hematológica adecuada
11. Función hepática adecuada
12. Función renal adecuada
13. Sin neuropatía periférica (<Grado 2)
14. Sin antecedentes conocidos de deficiencia de dihidropirimidina deshidrogenasa (DPD)

E.4

Principal exclusion criteria

1. Patients with ECOG performance status > or =2.
2. T1N0M0)or stage IV (TxNxM1) AJCC rectal cancer.
3. Any illness that the investigator considers will substantially increase the risk if the
patient participates in the study.
4. Pregnant or breast-feeding woman.
5. Chronically active hepatitis B or C virus infection.
6. Active uncontrolled infection.
7. History, within last year, or presence of unstable angina, myocardial infarction,
symptomatic congestive heart failure or asymptomatic left ventricular ejection
fraction < 50% (assessed by multiple-gated acquisition scan or equivalent by
ultrasound) or clinically significant valvular heart disease.
8. Peripheral neuropathy (> Grade 1)
9. Known history of dihydropyrimidine dehydrogenase deficiency (DPD)
10. Known or suspected reactions to any component of the study medication (5-FU,
leucovorin, irinotecan or oxaliplatin) or to components of similar chemical or
biologic composition.
11. Any phycological, familiar, sociological or geographical condition potentially
hampering compliance with the study protocol or follow-up schedule.
12. Concurrent participation in any other clinical trial likely to interfere with the
therapeutic schedule.
13. Patients that had received any previous treatment for their rectal cancer (surgery,
chemotherapy or radiotherapy).

1. Pacientes con estado de la repercusión funcional de la enfermedad ECOG > o = 2.
2. Cáncer rectal T1N0M0 o estadio IV (TxNxM1) según la clasificación AJCC TNM
3. Cualquier enfermedad que el investigador considere que aumentará sustancialmente el riesgo
si el paciente participa en el estudio.
4. Mujer embarazada o lactante.
5. Infección crónicamente activa del virus de la hepatitis B o C.
6. Infección activa no controlada.
7. Antecedentes médicos, durante el año anterior, o presencia actual de angina inestable, infarto
de miocardio, insuficiencia cardíaca congestiva sintomática o fracción de eyección ventricular
izquierda asintomática <50% (evaluada por la adquisición de conducto múltiple o equivalente
por ultrasonido) o enfermedad cardíaca valvular clínicamente significativa.
8. Neuropatía periférica (> Grado 1)
9. Antecedentes conocidos de deficiencia de dihidropirimidina deshidrogenasa (DPD)
10. Reacciones conocidas o sospechadas a cualquier componente de la medicación del estudio (5-
FU, leucovorin, irinotecan u oxaliplatin) o a componentes de composición química o biológica
similar.
11. Cualquier afección psicológica, o condición sociológica o geográfica que potencialmente pueda
obstaculizar el cumplimiento del protocolo de estudio o el calendario de seguimiento.
12. Participación simultánea en cualquier otro ensayo clínico que pudiese interferir con el plan
terapéutico.
13. Pacientes que han recibido algún tratamiento previo para su cáncer rectal (cirugía,
quimioterapia o radioterapia).

E.5 End points

E.5.1

Primary end point(s)

cCR rate (ycT0N0) in LARC patients treated with chemo - chemoradiation.

Tasa de Respuesta Clínica Completa (ycT0N0) en pacientes CRLA tratados con quimio-quimioradioterapia.

E.5.1.1

Timepoint(s) of evaluation of this end point

at 7-8 months

a los 7-8 meses

E.5.2

Secondary end point(s)

Efficacy:
• Overall survival: will be determined from the initiation date of chemotherapy
treatment to the date of death from any cause.
• Relapse-free survival or disease-free survival: will be determined by the length of
time after chemo – chemoradiotherapy treatment during which no disease is found.
Patient survives without any signs and symptoms of the cancer.
• Percentage of patients that follow the “watch-and-wait” surveillance protocol.

Safety:
• Overall toxicity: acute and late toxicity of neoadjuvant treatment (chemo and
chemoradiotherapy) according to the Common Toxicity Criteria (CTC) for adverse
events (AE).

Eficacia:
• Supervivencia global: se determinará desde la fecha de inicio del tratamiento de
quimioterapia hasta la fecha de fallecimiento por cualquier causa.
• Supervivencia libre de recaída o supervivencia libre de enfermedad: se determinará en función del tiempo transcurrido después del tratamiento con quimio - quimioradioterapia durante el cual no se manifiesta ninguna enfermedad. Esto es, el paciente sobrevive sin signos ni síntomas del cáncer.
• Porcentaje de pacientes que siguen el protocolo de seguimiento "watch & wait".

Seguridad
• Toxicidad general: toxicidad aguda y tardía del tratamiento neoadyuvante (quimioterapia
y quimiorradioterapia) según el CTCAE (“Common Toxicity Criteria for Adverse
Events”).

E.5.2.1

Timepoint(s) of evaluation of this end point

Efficacy: Through the study
Safety: Through the study

Eficacia: a lo largo del estudio
Seguridad: 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

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

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

2019-02-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-01-31

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

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