Clinical Trials Register

Summary
EudraCT Number:	2016-002529-12
Sponsor's Protocol Code Number:	CICL670F2203
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:	2017-08-02
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2016-002529-12

A.3

Full title of the trial

A phase II, multicenter, open-label, randomized two-year study to evaluate the efficacy and safety of deferasirox film-coated tablet versus phlebotomy in patients with Hereditary Hemochromatosis

Estudio de fase II, multicéntrico, abierto, aleatorizado de dos años de duración para comparar la eficacia y seguridad de deferasirox en comprimidos recubiertos frente a flebotomía en pacientes con hemocromatosis hereditaria

A.3.1

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

Study to evaluate the efficacy and safety of deferasirox film-coated tablet versus phlebotomy in patients with HH

Estudio para comparar la eficacia y seguridad de deferasirox en comprimidos recubiertos frente a flebotomía en pacientes con HH

A.4.1

Sponsor's protocol code number

CICL670F2203

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	Novartis Farmacéutica, S.A.
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Novartis Pharma AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Farmacéutica, S.A.
B.5.2	Functional name of contact point	Departamento médico
B.5.3	Address:
B.5.3.1	Street Address	Gran Vía de les Corts Catalanes, 764
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08013
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34900353036
B.5.5	Fax number	+34932479903
B.5.6	E-mail	eecc.novartis@novartis.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	Exjade
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
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	deferasirox
D.3.2	Product code	ICL670
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DEFERASIROX
D.3.9.1	CAS number	201530-41-8
D.3.9.2	Current sponsor code	ICL670
D.3.9.4	EV Substance Code	SUB21981
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	90
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	Exjade
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
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	deferasirox
D.3.2	Product code	ICL670
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DEFERASIROX
D.3.9.1	CAS number	201530-41-8
D.3.9.2	Current sponsor code	ICL670
D.3.9.4	EV Substance Code	SUB21981
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	180
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	Exjade
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
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	deferasirox
D.3.2	Product code	ICL670
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DEFERASIROX
D.3.9.1	CAS number	201530-41-8
D.3.9.2	Current sponsor code	ICL670
D.3.9.4	EV Substance Code	SUB21981
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	360
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

Hereditary Hemochromatosis

hemocromatosis hereditaria

E.1.1.1

Medical condition in easily understood language

Hereditary Hemochromatosis

hemocromatosis hereditaria

E.1.1.2

Therapeutic area

Diseases [C] - Eye Diseases [C11]

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	10057874
E.1.2	Term	Hereditary hemochromatosis
E.1.2	System Organ Class	100000012236

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

Assess the response rate in the deferasirox FCT and phlebotomy treatment arms where response is defined
by achieving target SF ≤ 100 μg/L on or before 24 months

Evaluar la tasa de respuesta en los brazos de tratamiento deferasirox FCT y flebotomía, donde la respuesta se
define como alcanzar el objetivo SF ≤ 100 μg/l durante o antes de 24 meses.

E.2.2

Secondary objectives of the trial

Key secondary:
Characterize the ocular safety of deferasirox FCT and phlebotomy over 24 months

Other secondary:
- Evaluate the safety and tolerability of deferasirox FCT and phlebotomy over 24 months.
- Assess the change from baseline in visual acuity, intra-ocular pressure, retina or/and optic nerve abnormalities, and lens abnormalities at months 6, 12, 18, and 24 of deferasirox FCT and phlebotomy.
- Assess the safety and tolerability of deferasirox FCT in patients who interrupt and re-initiate treatment due to SF ≤ 100 μg/L and ≥ 300 μg/L
- Assess the first time to response (defined as SF ≤ 100 μg/L) between the deferasirox and phlebotomy treatment groups

Objetivo secundario clave: Caracterizar la seguridad ocular de deferasirox FCT y flebotomía durante 24 meses.

Otros objetivos secundarios:
-Evaluar la seguridad y tolerabilidad de deferasirox FCT y flebotomía durante 24 meses.
-Evaluar el cambio respecto a la basal en agudeza visual, presión intra-ocular, anomalías de la retina y/o nervio óptico, y anomalías de las lentes a los meses 6, 12, 18, y 24 de deferasirox FCT y flebotomía.
-Evaluar la seguridad y tolerabilidad de deferasirox FCT en pacientes que interrumpan y reinicien el tratamiento debido a SF≤ 100 μg/l y ≥ 300 μg/l.
-Evaluar el primer tiempo hasta la respuesta (definido como SF ≤100 μg/l) entre los grupos de tratamiento de deferasirox y flebotomía.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Male or female ≥ 18-years-old
- Documented genotype testing confirming homozygous for the C282Y mutation (C282Y/C282Y)
- Transferrin saturation ≥ 45% (at either screening visit)
- Serum Ferritin ≥ 700 μg/L (at either screening visit)

-Hombre o mujer ≥ 18 años de edad
-Análisis de genotipo documentado que confirme homocigosis para la mutación C282Y (C282Y/C282Y)
-Saturación de transferrina ≥ 45% (en cualquier visita de selección)
-SF ≥ 700 μg/l (en cualquier visita de selección)

E.4

Principal exclusion criteria

1. Medical conditions that preclude inclusion:
- Iron overload not due to HH
- Condition which might significantly alter the absorption, distribution, metabolism or excretion of oral deferasirox
- Systemic disease which prevents taking study treatment or any contraindication to phlebotomy
- Inflammatory condition or immunological disease which may interfere with the SF interpretation, such as an active infection, collagen vascular disorders, irritable bowel syndrome, lupus, or immune thrombocytopenia
- Significantly impaired gastrointestinal function or disease that may significantly alter the absorption of oral deferasirox, e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption
2. Prior iron chelation therapy, prohibited concomitant medications with deferasirox
syndrome, or small bowel resection.
- Psychiatric or addictive disorder which prevent giving informed consent or undergoing any of the treatment options or unwilling or unable to comply with the protocol
- Uncontrolled or significant cardiac disease or symptomatic cardiac arrhythmias, e.g., sustained ventricular tachycardia and clinically significant second or third degree AV block without a pacemaker
- Illicit drug use and/or alcohol use, defined as an average alcohol consumption greater than one standard drink a day for women or two standard drinks a day for men within the 12 months prior to enrolment.
- Cirrhosis, including Child-Pugh class A, B, and C, diagnosed by liver biopsy, elastography, radiologic exams, or clinical criteria.
- Active hepatitis B or C (hepatitis B carrier will be allowed)
- History of HIV seropositivity (ELISA or Western blot)
- Malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, except localized basal cell carcinoma of the skin, or any history of hepatocellular carcinoma
3. Abnormal laboratory values
4. Participation in an investigational study:
- Observational registry study is allowable
- Within 30 days prior to enrollment or within 5-half-lives of an investigational product, whichever is longer
- Treatment with a systemic investigational drug within 4 weeks or topical investigational drug within 7 days of starting the study
5. Pregnancy and contraception:
- Pregnant or nursing (lactating) women
- Women of child-bearing potential unless using basic methods of contraception
- Post-menopausal and not of childbearing potential if she has had 12 months of natural (spontaneous) amenorrhea with an expected clinical profile

1. Condiciones médicas que eviten la inclusión:
-Sobrecarga de hierro no debida a HH.
-Condición que podría alterar significativamente la absorción, distribución, metabolismo o excreción de deferasirox oral.
-Enfermedad sistémica que impida tomar el tratamiento del estudio o cualquier contraindicación para flebotomía.
-Condición inflamatoria o enfermedad inmunológica que puede interferir con la interpretación de SF, como una infección
activa, alteraciones vasculares del colágeno, síndrome del intestino irritable, o trombocitopenia inmunológica.
-Función gastrointestinal alterada significativamente o enfermedad que pueda alterar significativamente la absorción
de deferasirox oral, p.ej., enfermedades ulcerosas, nauseas no controladas, vómitos, diarrea, síndrome de malabsorción,
o resección del intestino delgado.
-Alteración psiquiátrica o adictiva que impida dar el consentimiento informado o seguir alguna de las opciones de
tratamiento o no querer o ser incapaz de cumplir con el protocolo.
-Enfermedad cardiaca no controlada o significativa o arritmias cardiacas sintomáticas, p.ej., taquicardia ventricular sostenida y bloqueo AV de segundo o tercer grado clínicamente significativo sin un marcapasos.
-Uso de fármacos ilícitos y/o uso de alcohol, definido como un consumo promedio de alcohol superior a una bebida estándar al día para mujeres o dos bebidas estándar al día para hombres en un plazo de 12 meses antes del reclutamiento.
-Cirrosis, incluyendo Child-Pugh de clase A, B y C, diagnosticado mediante biopsia hepática, elastografía, exploraciones radiológicas, o criterios clínicos.
-Hepatitis B o C activa (se permite portador de hepatitis B).
-Historia de seropositividad al VIH (ELISA o Western blot).
-Neoplasia de algún sistema de órganos, tratados o sin tratar, durante los últimos 5 años independientemente de si hay o no evidencia de recurrencia local o metástasis, except carcinoma de células basales localizado de la piel, o algún
antecedente de carcinoma hepatocelular.
2. Terapia quelante de hierro previa, medicaciones concomitants prohibidas con deferasirox.
3. Anomalías de los valores de laboratorio
4. Participación en un estudio en investigación:
-Un estudio de registro observacional es permisible.
-En los 30 días antes del reclutamiento o en las 5 vidas medias de un producto en investigación, lo que sea más largo.
-Tratamiento con un fármaco sistémico en investigación en las 4 semanas o fármaco tópico en investigación en los 7 días
del inicio del estudio.
5. Embarazo y anticonceptivos:
-Mujeres embarazadas o en periodo de lactancia.
-Mujeres en edad fértil a menos que utilicen métodos anticonceptivos básicos.
-Mujer postmenopáusica y en edad no fértil si ha tenido 12 meses de amenorrea natural (espontánea) con un perfil
clínico esperado.

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients achieving target SF ≤ 100 μg/L for the first time

Proporción de pacientes que alcanzan un SF ≤ 100 μg/L por primera vez

E.5.1.1

Timepoint(s) of evaluation of this end point

24 months

24 meses

E.5.2

Secondary end point(s)

Key secondary:
Incidence of ocular AEs overall and by severity, type of AE, and relation to study treatment

Other secondary:
- Incidence of AEs, AEs leading to discontinuation from study, laboratory abnormalities, and deaths
- Change from baseline at months 6, 12, 18 and 24 in visual acuity, tonometry, slit lamp, and fundus exams
- Incidence of AEs in patients who interrupt due to reaching target SF ≤ 100 μg/L, then re-initiate therapy at ≥ 300 μg/L
- Time to reach target SF ≤ 100 μg/L in the deferasirox and phlebotomy arms for the first time

Variable secundaria clave:
Incidencia de acontecimientos adversos oculares en general y por severidad, tipo de EA y relacion con el tratamiento del studio.

Otras variables secundarias:
-Incidencia de EAs, AEs que conducen a la descontinuación del estudio, anomalías de laboratorio y defunciones
- Cambio de la línea basal a los meses 6, 12, 18 y 24 en la agudeza visual, la tonometría, exploracion con lámpara de hendidura y exploracion del fondo de ojo.
- Incidencia de EAs en pacientes que interrumpen debido a que alcanzan el objetivo SF ≤ 100 μg / L, luego reinician la terapia cuando SF ≥ 300 μg / L
- Tiempo para alcanzar el objetivo SF ≤ 100 μg / L en los brazos de deisosirox y flebotomía por primera vez

E.5.2.1

Timepoint(s) of evaluation of this end point

- 24 months

- 24 months
- 6, 12, 18 and 24 months
- 24 months
- 24 months

-24 meses

-24 meses
-6, 12, 18 y 24 meses
-24 meses
-24 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

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

Yes

E.8.1.1

Randomised

Yes

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

Yes

E.8.2.3.1

Comparator description

flebotomía

phlebotomy

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Austria

Belgium

Bulgaria

France

Germany

Romania

Russian Federation

Slovakia

Spain

Switzerland

Turkey

United States

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 (EOS) occurs after the last patient has completed the last visit which includes a 30-day safety follow-up. This last patient may have either completed 24 months (104 weeks) of treatment or prematurely discontinued and completed ocular assessments.

El fin del tratamiento (EOT) ocurre después que el último paciente haya completado la última visita que incluye un seguimiento de seguridad de 30 días. Este último paciente puede haber completado 24 meses (104 semanas) de tratamiento o haberse retirado prematuramente y completado las evaluaciones oculares.

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:

120

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

120

F.4.2.2

In the whole clinical trial

150

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 of care

Tratamiento estándar

G. Investigator Networks to be involved in the Trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-10-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-10-16

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

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