Clinical Trials Register

Summary
EudraCT Number:	2009-016727-53
Sponsor's Protocol Code Number:	P-Monofer-CIA-01
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-11-12
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

2009-016727-53

A.3

Full title of the trial

A phase III, randomized, open-label study of intravenous iron isomaltoside 1000 (Monofer®) as mono therapy (without erythropoeisis stimulating agents) in comparison with oral iron sulfate in subjects with non-myeloid malignancies associated with Chemotherapy Induced Anemia (CIA).

Estudio de fase III, abierto y aleatorizado sobre el tratamiento en monoterapia (sin agentes estimuladores de la eritropoyesis) con hierro isomaltósido 1000 (Monoferro®) por vía intravenosa en comparación con el sulfato de hierro por vía oral en pacientes con cáncer no mieloide asociado a anemia inducida por quimioterapia (AIQ)

A.3.1

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

A study to compare isomaltoside 1000 (Monofer®)(taken as injections) with iron sulfate taken as tablets in patients who have cancer and anemia caused by their treatment.

Estudio para comparar hierro isomaltósido 1000 (Monofer®) ( adminstrado como inyecciones) con sulfato de hierro como comprimidos en pacientes con cáncer y anemia causada por su tratamiento.

A.3.2

Name or abbreviated title of the trial where available

P-Monofer-CIA-01

A.4.1

Sponsor's protocol code number

P-Monofer-CIA-01

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01145638

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	Pharmacosmos A/S
B.1.3.4	Country	Denmark
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	Pharmacosmos A/S
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Pharmacosmos A/S
B.5.2	Functional name of contact point	VP, CMO (Lars Lykke Thomsen)
B.5.3	Address:
B.5.3.1	Street Address	Roervangsvej 30
B.5.3.2	Town/ city	Holbaek
B.5.3.3	Post code	4300
B.5.3.4	Country	Denmark
B.5.4	Telephone number	+455948 5935
B.5.6	E-mail	llt@pharmacosmos.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	Monoferro 100 mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	Pharmacosmos A/S
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.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous bolus use (Noncurrent) Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Hierro Isomaltósido 1000
D.3.9.1	CAS number	9004-66-4
D.3.9.3	Other descriptive name	Complejo hierro isomalto-oligosacárido
D.3.9.4	EV Substance Code	SUB14268MIG
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	100
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	Comparator
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	Ferro Duretter, comprimido de liberación prolongada.
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline Consumer Healthcare AB
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	Ferro Duretter, prolonged release tablet
D.3.4	Pharmaceutical form	Prolonged-release 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	sulfato ferroso
D.3.9.3	Other descriptive name	SULFATO FERROSO
D.3.9.4	EV Substance Code	SUB11967MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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

Patients with non-myeloid malignancies associated with Chemotherapy Induced Anemia (CIA).

Pacientes con cáncer no mieloide asociado a anemia inducida por quimioterapia (AIQ).

E.1.1.1

Medical condition in easily understood language

Patients with malignancies that have not their origin in the bone marrow or spinal cord, or a resemblance to the marrow or spinal cord, and who has anemia caused by chemotherapy.

Pacientes con cáncer que no tiene su origen en la médula ósea o espinal, y con anemia causada por quimioterapia.

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10064014
E.1.2	Term	Cancer anemia
E.1.2	System Organ Class	10005329 - Blood and lymphatic system disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10022972
E.1.2	Term	Iron deficiency anaemia
E.1.2	System Organ Class	10005329 - Blood and lymphatic system disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of the study is:
-To demonstrate that intravenous iron isomaltoside 1000 is non-inferior to oral iron sulfate in the ability to increase hemoglobin (Hb) in patients with chemotherapy induced anemia and either absolute or functional iron deficiency.

Demostrar que la capacidad del hierro isomaltósido 1000 por vía intravenosa para aumentar los niveles de hemoglobina (Hb) no es inferior a la del sulfato de hierro por vía oral en pacientes con anemia inducida por quimioterapia y con déficit absoluto o funcional de hierro.

E.2.2

Secondary objectives of the trial

The secondary objectives are:
-To obtain safety reassurance with the use of iron isomaltoside 1000 (Monofer®) for the correction of CIA in subjects with non-myeloid malignancies.
-To compare study drug related adverse events after iron isomaltoside 1000 (Monofer®) to study drug related adverse events in subjects treated with oral iron sulfate.
-To compare iron related hematological parameters (hemoglobin (Hb), transferrin saturation (TfS), serum iron, and serum ferritin levels).
-To assess subjects who discontinue study due to lack of response or intolerance.
-To assess Quality of Life.
-Assessment of RLS symptoms and change in these symptoms during the study.
-To detect the impact of the study drug upon the ability to complete the planned chemotherapy
-To detect the impact of the study drug upon response to the chemotherapy

-Obtener un índice fiable de seguridad con el uso de hierro isomaltósido 1000 (Monoferro®) para la corrección de la AIQ en pacientes con neoplasias malignas no mieloides.
-Comparar los acontecimientos adversos relacionados con el fármaco del estudio tras el tratamiento con hierro isomaltósido 1000 (Monoferro®) con los acontecimientos adversos relacionados con el fármaco del estudio en los pacientes tratados con sulfato de hierro oral.
-Comparar los parámetros hematológicos relacionados con el hierro (niveles de hemoglobina [Hb], saturación de transferrina [ST], hierro sérico y ferritina sérica).
-Evaluar a los pacientes que abandonen el estudio por falta de respuesta o intolerancia.
-Evaluar la calidad de vida.
-Evaluar los síntomas del SPI y el cambio en estos síntomas durante el estudio.
-Detectar el impacto del fármaco del estudio en la capacidad para completar la quimioterapia programada
-Detectar el impacto del fármaco del estudio en la respuesta a la quimioterapia

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion criteria:
1. Men and women, aged more than 18 years.
2. Subjects diagnosed with non-myeloid malignancies ( including all solid tumors, Low Grade Lymphoma (LGL), Chronic Lymphatic Leukemia (CLL) and Myeloma) receiving chemotherapy at least 1 day prior to screening and who are going to receive at least two more chemotherapy cycles.
3. Hb < 12 g/dL (7.4 mmol/L).
4. TfS <50%.
5. Serum Ferritin <800 ng/ml.
6. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
7. Willingness to participate after informed consent (including HIPAA, if applicable).

1.Varones y mujeres mayores de 18 años.
2.Pacientes con diagnóstico de cáncer no mieloide (incluido cualquier tipo de tumor sólido, linfoma de bajo grado (LBG), leucemia linfocítica crónica [LLC] y mieloma) que reciban quimioterapia al menos 1 día antes de la selección y que vayan a recibir al menos dos ciclos más de quimioterapia.
3.Hb < 12 g/dl (7,4 mmol/l).
4.ST < 50 %.
5.Ferritina sérica < 800 ng/ml.
6.Estado funcional de 0 a 2 según el Eastern Cooperative Oncology Group (ECOG).
7.Voluntad para participar después de la obtención del consentimiento informado (incluida HIPAA, si procede).

E.4

Principal exclusion criteria

Exclusion criteria:
1. Anemia caused primarily by other factors than CIA.
2. IV or oral iron treatment within 4 weeks prior to screening visit.
3. Erythrypoietin treatment within 4 weeks prior to screening visit.
4. Blood transfusion within 4 weeks prior to screening visit.
5. Imminent expectation of blood transfusion on part of treating physician.
6. Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
7. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulfate).
8. Known hypersensitivity to any excipients in the investigational drug products.
9. Subjects with a history of multiple allergies.
10. Decompensated liver cirrhosis and hepatitis (alanine aminotransferase (ALAT) > 3 times upper normal limit).
11. History of Immunocompromise and/or history of Hepatitis B and/or C.
12. Active acute or chronic infections (assessed by clinical judgement and if deemed necessary by investigator supplied with white blood cells (WBC) and C-reactive protein (CRP)).
13. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
14. Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches).
15. Planned elective surgery during the study.
16. Participation in any other clinical study (except chemotherapy protocol) within 3 months prior to screening.
17. Known intolerance to oral iron treatment.
18. Untreated B12 or folate deficiency.
19. Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.

1.Anemia causada principalmente por otros factores distintos de AIQ.
2.Tratamiento con hierro por vía IV u oral 4 semanas antes de la visita de selección.
3.Tratamiento con eritropoyetina 4 semanas antes de la visita de selección.
4.Transfusión sanguínea 4 semanas antes de la visita de selección.
5.Expectativa inminente de transfusión de sangre por parte del médico encargado del tratamiento.
6.Sobrecarga de hierro o trastornos en la utilización del hierro (p. ej., hemocromatosis y hemosiderosis).
7Hipersensibilidad al fármaco (es decir, hipersensibilidad previa al hierro dextrano, a complejos de hierro mono o disacárido o al sulfato de hierro).
8.Hipersensibilidad conocida a alguno de los excipientes de los fármacos en investigación.
9.Pacientes con antecedentes de alergias múltiples.
10.Cirrosis hepática descompensada y hepatitis (alanina-aminotransferasa [ALT] > 3 veces el límite superior de la normalidad).
11.Antecedentes de inmunodeficiencia y/o antecedentes de hepatitis B y/o C.
12.Infecciones agudas o crónicas activas (evaluadas según criterios clínicos y, si el investigador lo considera necesario, con administración de leucocitos [LEU] y proteína C-reactiva [PCR]).
13.Artritis reumatoide con síntomas o signos de inflamación articular activa.
14.Embarazo y lactancia. Para evitar un embarazo, las mujeres tienen que ser posmenopáusicas (deben haber transcurrido al menos 12 meses desde la última menstruación), estar esterilizadas quirúrgicamente o, en el caso de mujeres con capacidad reproductora, deben usar uno de los siguientes métodos anticonceptivos durante todo el periodo del estudio y, tras su finalización, durante al menos 5 veces la semivida biológica plasmática del producto en fase de investigación: anticonceptivos orales, dispositivos intrauterinos (DIU), inyecciones anticonceptivas depot (gestágeno de liberación prolongada), implantación subcutánea, anillo vaginal y parches transdérmicos).
15.Cirugía programada para su realización durante el estudio.
16.Participación en otro estudio clínico (excepto protocolos de quimioterapia) en los 3 meses previos a la selección.
17.Intolerancia conocida al tratamiento con hierro por vía oral.
18.Deficiencia de vitamina B12 o folato no tratada.
19.Cualquier otra afección médica que, en opinión del investigador principal, pueda hacer que el paciente no finalice el estudio o le exponga a un posible riesgo por su participación en el estudio. Por ejemplo, hipertensión no controlada, cardiopatía isquémica inestable o diabetes mellitus no controlada.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint of the study is:
Change in Hb concentration from baseline to week 12.

Variación en la concentración de Hb desde el periodo basal hasta la semana 12.

E.5.1.1

Timepoint(s) of evaluation of this end point

From baseline to week 12.

Desde la vsita Basal hasta la semana 12.

E.5.2

Secondary end point(s)

The secondary end points are:
-Number of subjects who achieve target limits of Hb (men 13?18 g/dL, women 12-16 g/dL) and have change in Hb concentration > 1.0 g/dL at week 2, 4, 8, and 12.
-Safety laboratory assessments at baseline and 1, 2, 4, 8, 12 and 24 weeks.
-Number of study drug related adverse events (including serious adverse reactions) in iron isomaltoside 1000 (Monofer®) group and iron sulfate group.
-Number of subjects receiving transfusions.
-Concentrations of Hb, serum ferritin, serum iron and TfS measured at baseline and 1, 2, 4, 8,12
and 24 weeks.
-Number of subjects in each randomization group who discontinue study because of lack of response or intolerance of investigational drugs.
-Changes in Quality of Life at baseline, 4 and 12 weeks.
-Change in RLS symptoms (RLS score) from baseline to week 12 in subjects with RLS symptoms at baseline.
-Impact of study drug on ability to complete chemotherapy assessed as yes or no response at 24 weeks.
-Impact of study drug on response to chemotherapy, assessed as complete remission, partial remission, stable remission and progressive disease as per the investigator discretion at 24 weeks.

-Número de pacientes que alcancen los límites objetivo de Hb (varones 13 - 18 g/dl, mujeres 12 - 16 g/dl) y una variación en la concentración de Hb > 1,0 g/dl en las semanas 2, 4, 8 y 12.
-Pruebas analíticas de seguridad en el periodo basal y en las semanas 1, 2, 4, 8, 12 y 24.
-Número de acontecimientos adversos relacionados con el fármaco del estudio (incluidas las reacciones adversas graves) en el grupo tratado con hierro isomaltósido 1000 (Monoferro®) y en el grupo de sulfato de hierro.
-Número de pacientes que reciben transfusiones.
-Concentraciones de Hb, ferritina sérica, hierro sérico y ST determinadas en el periodo basal y en las semanas 1, 2, 4, 8, 12 y 24.
-Número de pacientes en cada grupo de aleatorización que abandonan el estudio debido a una falta de respuesta o intolerancia al fármaco en investigación.
-Cambios en la calidad de vida en el periodo basal y las semanas 4 y 12.
-Cambio en los síntomas del SPI (puntuación del SPI) desde el periodo basal hasta la semana 12 en pacientes con síntomas de SPI en el periodo basal.
-Impacto del fármaco del estudio sobre la capacidad para completar la quimioterapia, evaluado mediante una respuesta sí o no a las 24 semanas.
-Impacto del fármaco de estudio en la respuesta a la quimioterapia, evaluado como remisión completa, remisión parcial, remisión estable y enfermedad progresiva, según el criterio del investigador, a las 24 semanas.

E.5.2.1

Timepoint(s) of evaluation of this end point

Time point(s) are specified in each secondary endpoints.

Los momentos de evaluación estan especificados en cada variable secundaria.

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

Yes

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)

Yes

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

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

Denmark

Germany

India

Poland

Russian Federation

Spain

Sweden

United Kingdom

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

The end of study is defined by the completion of the last subject's last visit in any participating centre.

LVLS

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

E.8.9.2

In all countries concerned by the trial 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:

300

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Information not present in EudraCT

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

150

F.4.2.2

In the whole clinical trial

350

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)

After the end of the study or if subject is withdrawn from the study, the subject will be treated according to standard hospital practice.

Al finalizar el ensayo o si el sujeto es retirado prematuramente del ensayo, el sujeto será tratado según práctica clínica habitual.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-01-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-12-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-04-23

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