Clinical Trials Register

Summary
EudraCT Number:	2016-003604-31
Sponsor's Protocol Code Number:	PREFER-HF
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:	2016-11-17
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

2016-003604-31

A.3

Full title of the trial

Effects of intravenous iron therapy with ferric carboxymaltose compared with oral iron
therapy in heart failure with preserved ejection fraction and iron deficiency. ( PREFER-HF)

Efecto sobre la capacidad funcional del tratamiento con hierro intravenoso o hierro oral, comparado con placebo, en pacientes con insuficiencia cardiaca con fracción de eyección del ventrículo izquierdo preservada y anemia ferropénica. ( PREFER-HF)

A.3.1

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

Effects of intravenous iron therapy with ferric carboxymaltose compared with oral iron
therapy in heart failure with preserved ejection fraction and iron deficiency. ( PREFER-HF)

A.3.2

Name or abbreviated title of the trial where available

PREFER-HF

A.4.1

Sponsor's protocol code number

PREFER-HF

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	José Luis Morales Rull, Institut de Recerca Biomédica Lleida IRB Hospital Arnau de Vilanova Servicio de Medicina Interna
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	Fundació La Marató de TV3
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	Institut de Recerca Biomèdica de Lleida (IRB)
B.5.2	Functional name of contact point	Servicio Científico Técnico Farma
B.5.3	Address:
B.5.3.1	Street Address	Avenida Alcalde Rovira Roure, 80
B.5.3.2	Town/ city	Lleida
B.5.3.3	Post code	25198
B.5.3.4	Country	Spain
B.5.4	Telephone number	+3497370 52 36
B.5.5	Fax number	+3497370 24 32
B.5.6	E-mail	SCTFarma@irblleida.cat

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	Ferinject 50 mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	Vifor France S.A.
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 injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FERRIC CARBOXYMALTOSE
D.3.9.1	CAS number	9007-72-1
D.3.9.4	EV Substance Code	SUB66620
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.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	Ferro sanol 100 mg.
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB PHARMA, S.A.
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	Capsule, hard
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	GLYCINE FERROUS SULFATE PENTAHYDRATE COMPLEX
D.3.9.3	Other descriptive name	GLYCINE FERROUS SULFATE PENTAHYDRATE COMPLEX
D.3.9.4	EV Substance Code	SUB127245
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	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: 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	Fisiogen Ferro Forte 30 mg.
D.2.1.1.2	Name of the Marketing Authorisation holder	ZAMBON S.A.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.3.4	Pharmaceutical form	Capsule, hard
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	FERRIC PYROPHOSPHATE
D.3.9.1	CAS number	10058-44-3
D.3.9.3	Other descriptive name	FERRIC PYROPHOSPHATE
D.3.9.4	EV Substance Code	SUB13847MIG
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	350
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection/infusion
D.8.4	Route of administration of the placebo	Intravenous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients with heart failure with preserved ejection fraction ( HFpEF) and iron deficency anemia.

Pacientes con insuficiencia cardiaca (IC) con fracción de eyección del ventrículo izquierdo (FEVI) preservada y anemia ferropénica.

E.1.1.1

Medical condition in easily understood language

Patients with heart failure with preserved ejection fraction ( HFpEF) and iron deficency anemia.

Pacientes con insuficiencia cardiaca (IC) con fracción de eyección del ventrículo izquierdo (FEVI) preservada y anemia ferropénica.

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Assess whether intravenous treatment with iron carboxymaltose or oral treatment (ferroglicina iron sulfate or liposome) in patients with HF Preserved LVEF and iron deficiency anemia, can improve functional capacity measured by the 6-minute walk (6MWT) test compared to placebo at 30 weeks after the start of treatment.

Valorar si el tratamiento intravenoso con hierro carboximaltosa o hierro oral ( ferroglicina sulfato o hierro liposomado) en pacientes con IC con FEVI preservada y anemia ferropénica, pueden mejorar la capacidad funcional medida mediante la prueba de la marcha de 6 minutos (PM6M) en comparación con el placebo, a las 30 semanas del inicio del tratamiento.

E.2.2

Secondary objectives of the trial

To determine whether IV ferric carboxymaltose improve NYHA class and quality of life (Living
with Heart Failure Minessota questionnaire), and reduce mortality and hospitalizations, in patients with HFpEF in comparison with oral iron.

.Conocer mejor la etiología de la anemia asociada a la IC con FEVI preservada.
.Valorar en que medida el tratamiento con hierro intravenoso o con hierro oral se traduce en una mejoría de la PM6M a las 6, 12 , 24 y 30 semanas.
.Valorar en que medida el tratamiento con hierro intravenoso o con hierro oral se traduce en una mejoría de los síntomas de insuficiencia cardiaca a las 6, 12, 24 y 30 semanas.
. Determinar si el tratamiento con hierro carboximaltosa mejora la clase funcional NYHA, la calidad de vida, y reduce la mortalidad u hospitalizaciones, en comparación con el hierro oral

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subjects with stable chronic HF (NYHA II/IV functional class) on optimal background therapy (as determined by the investigator) for at least 4 weeks with no dose changes of heart failure drugs during the last 2 weeks (with the exception of diuretics). In general, optimal
pharmacological treatment should include an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker and a beta blocker unless contraindicated or not tolerated and diuretic if indicated.
2. Left ventricular ejection fraction >45% (value within 3 months of planned date of randomization).
3. BNP >100 pg/mL and/or N-terminal-pro-BNP >400 pg/mL at the screening visit.
4. Subject must be capable of completing the 6MWT.
5. Screening serum ferritin <100 ng/mL or 100–300 ng/mL with transferrin saturation <20%.
6. At least 18 years of age.
7. Before any study-specific procedure, the appropriate written informed consent must be obtained.

1. Pacientes hombres o mujeres con edad igual o superior a 18 años de edad, edad capaces de entender la hoja de información al paciente y otorgar su consentimiento (en caso contrario se prevé que pueda otorgar dicho consentimiento un familiar o tutor legal competente para ello).
2. Pacientes con IC crónica y FEVI preservada según los criterios de la Sociedad Europea de Cardiología en clase funcional II-IV NYHA.
3. BNP >35 pg/mL y/o N-terminal-pro-BNP >125 pg/mL en el momento de inclusión.
4.Ingreso por descompensación por lo menos en una ocasión.
5.Ferritina sérica <100ng/mL o 100–300ng/mL y IST <20% y anemia (Hb <13g/dL en hombres, 12g/dL en mujeres).
5. El paciente debe ser capaz de realizar el PM6M.
7. Los pacientes (familiar o tutor legal) deberán otorgar su consentimiento informado por escrito para participar en el estudio y antes de que se realice ninguna de las evaluaciones relacionadas con el estudio.

E.4

Principal exclusion criteria

1. Subject has known sensitivity to any of the products to be administered during dosing.
2. History of acquired iron overload.
3. History of erythropoietin-stimulating agent, i.v. iron therapy, and/or blood transfusion in previous 6 weeks prior to randomization.
4. Oral iron therapy at doses >100 mg/day in previous 1 week prior to randomization. Note: ongoing use of multivitamins containing
iron <75 mg/day is permitted.
5. Body weight =/<35 kg.
6. Exercise training programme(s) in the 3 months prior to screening or planned in the next 6 months.
7. Subject at an immediate need of transfusion or haemoglobin >/= 15 g/dL.
8. Known active bacterial infection.
9. Chronic liver disease (including active hepatitis) and/or screening alanine transaminase or aspartate transaminase above three times the upper limit of the normal range.
10. Subjects with known hepatitis B surface antigen positivity and/or hepatitis C virus ribonucleic acid positivity.
11. Vitamin B12 and/or serum folate deficiency. If deficiency-corrected subject may be rescreened for inclusion.
12. Subjects with known seropositivity to human immunodeficiency virus.
13. Clinical evidence of current malignancy with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia.
14. Currently receiving systemic chemotherapy and/or radiotherapy.
15. Renal dialysis (previous, current, or planned within the next 6 months).
16. Unstable angina pectoris as judged by the investigator; severe valvular or left ventricular outflow obstruction disease needing intervention; atrial fibrillation/flutter with a mean ventricular response rate at rest >100 beats per minute.
17. Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack, or stroke within the last 3 months prior to randomization.
18. Coronary artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, and aortic; diagnostic catheters are allowed), or major surgery, including thoracic and cardiac surgery, within the last 3 months prior to randomization.
19. Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(ies), or subject is receiving other investigational agent(s).
20. Subject of childbearing potential who is pregnant (e.g. positive human chorionic gonadotropin test) or is breastfeeding.
21. Subject is not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication.
22. Subject previously randomized to this study. Note: subjects may be rescreened if they fail any of the screening procedures. If rescreened, all tests must fall inside the maximum specified screening windows for each criterion.
23. Subject will not be available for all protocol-specified assessments.
24. Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
25. Lactose intolerance.
26. Pregnant woman.

1. Alergia o intolerancia a cualquiera de los tratamientos que se administran en el estudio.
2. Ausencia de ecocardiograma en los 6 meses previos.
3. Niveles plasmáticos de BNP < 35 pg/ml o de NT-pBNP< 125 pg/ml
4. Antecedentes de hemocromatosis, hemorragia aparente: sangrado gastrointestinal, hipermenorrea, evidencia de enfermedad inflamatoria intestinal.
5. Enfermedades neoplásicas (excepto carcinoma baso celular o escamoso de la piel y neoplasia cervical intraepitelial) que reciban o no, tratamientos quimioterápicos y/o radioterapia.
6. Antecedentes de EPO, hierro ev y/o transfusión sanguínea en las últimas 6 semanas previas a la randomización.
7. Hierro oral con dosis de >100mg/día en la última semana antes de la randomización.
8. Pacientes con necesidad inmediata de transfusión.
9. Déficit de vitamina B12 y/o déficit de folato. Si se corrige el déficit el paciente podría ser cribado de nuevo para su inclusión.
10. Pacientes con insuficiencia renal crónica en diálisis (previa, en el momento de screening o planificada en los próximos 6 meses).
11. Hipotiroidismo no tratado.
12. Enfermedad hepática crónica (incluido hepatitis activa) y/o elevación de AST o ALT > 3 veces el límite superior de la normalidad.
13. Angina inestable, valvulopatía severa u obstrucción de la salida del ventrículo izquierdo que requieran intervención.
14. Fibrilación auricular o flutter con respuesta ventricular media superior a 100lpm.
15. Infarto agudo de miocardio o síndrome coronario agudo, accidente isquémico transitorio o ictus en los últimos 3 meses previo a la randomización.
16. By-pass coronario o intervencionismo percutáneo (ej. cardíaco, cerebrovascular y aórtico), cirugía mayor, incluido cirugía torácica y cardíaca en los últimos 3 meses previo a la randomización.
17. Paciente incluido en otro estudio o que ha participado en uno en el último mes.
18. Paciente en programa de entrenamiento físico en los últimos 3 meses o planeado en los próximos 6 meses.
19. Cualquier condición que, en opinión del Investigador, pueda poner en peligro la evaluación de la eficacia o seguridad.
20. El paciente no podrá acudir a todas las evaluaciones especificadas en el protocolo.
21. El paciente presenta alguna discapacidad que compromete la capacidad para comprender y/o firmar el consentimiento y/o para cumplir los procedimientos del estudio.
22. Falta de aceptación por parte del paciente para participar en el estudio.
23. Pacientes con expectativa de vida inferior a 6 meses en el momento del ingreso no atribuible a la propia insuficiencia cardiaca.
24. Intolerancia a la lactosa.
25. Embarazo

E.5 End points

E.5.1

Primary end point(s)

Change in 6MWT distance from baseline to Week 24 visit after the start of investigational drug.

Cambio en la distancia PM6M desde el inicio hasta la semana 24 después de la visita de inicio del fármaco en investigación .

E.5.1.1

Timepoint(s) of evaluation of this end point

24 weeks

24 semanas

E.5.2

Secondary end point(s)

- Change in NYHA class at Weeks 6, 12, 24 and 30
- Change Kansas City Cardiomyopathy questionnaire (KCCQ to to Weeks 6, 12, 24 and 30
- Rate of any, HF-related or other cardiovascular hospitalizations.
- Time to the first hospitalization for any reason, for worsening of CHF, other cardiovascular-related events, or for any cardiovascular reason.

Clase funcional de la NYHA
Cuestionario de miocardiopatía de Kansas City
Reducción de la hospitalización
Reducción de la mortalidad

E.5.2.1

Timepoint(s) of evaluation of this end point

Weeks 6, 12, 24 and 30

Semanas 6,12, 24 and 30

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

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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)

Yes

E.8.2.2

Placebo

Yes

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

Yes

E.8.4

The trial involves multiple sites in the 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

LVLS

Visita final 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

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:

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2016-11-17.

Yes

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)

None

Ninguno

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

2017-02-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-02-03

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

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IMP with orphan designation in the indication
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