Clinical Trials Register

Summary
EudraCT Number:	2013-005549-35
Sponsor's Protocol Code Number:	E10030-02
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:	2014-01-20
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

2013-005549-35

A.3

Full title of the trial

An open-label investigator sponsored trial to investigate the safety, tolerability and development of subfoveal fibrosis by intravitreal administration of altering regimens of FovistaTM (Anti-PDGF-B pegylated aptamer) and Anti-VEGF therapy (Lucentis®, Avastin® or Eylea®) in subjects with neovascular age-related macular degeneration.

Ensayo clínico abierto para investigar la seguridad, tolerabilidad y el desarrollo de la fibrosis subfoveal a través de la administración intravitrea de regímenes alternos de FOVISTA? (aptámero pegilado anti PDGT-B) y terapia anti-VEGF (Lucentis®, Avastin® o Eylea®) en pacientes con degeneración macular neovascular asociada a la edad.

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

E10030-02

A.4.1

Sponsor's protocol code number

E10030-02

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	Barcelona Macula Foundation Research for Vision
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	Barcelona Macula Foundation
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	Trial Form Support, S.L.
B.5.2	Functional name of contact point	Elisabet Molina
B.5.3	Address:
B.5.3.1	Street Address	Consell de Cent, 334 - 4ª planta
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08009
B.5.3.4	Country	Spain
B.5.4	Telephone number	34931850200
B.5.5	Fax number	34931850257
B.5.6	E-mail	elisabet.molina@tfscro.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	No
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	Fovista
D.3.2	Product code	E10030
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	Intravitreal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Fovista
D.3.9.1	CAS number	144930-73-1
D.3.9.2	Current sponsor code	E10030
D.3.9.3	Other descriptive name	E10030
D.3.9.4	EV Substance Code	SUB126298
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	30
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	Lucentis 10 mg/mL
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVARTIS EUROPHARM LTD
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	Lucentis
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	Intravitreal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RANIBIZUMAB
D.3.9.1	CAS number	347396-82-1
D.3.9.4	EV Substance Code	SUB22314
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	0.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Eylea
D.2.1.1.2	Name of the Marketing Authorisation holder	BAYER PHARMA AG
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	Eylea
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	Intravitreal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AFLIBERCEPT
D.3.9.3	Other descriptive name	AFLIBERCEPT
D.3.9.4	EV Substance Code	SUB26987
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	2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Avastin
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Pharma AG
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	Avastin
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	Intravitreal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BEVACIZUMAB
D.3.9.1	CAS number	216974-75-3
D.3.9.2	Current sponsor code	BEVACIZUMAB
D.3.9.4	EV Substance Code	SUB16402MIG
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	1.25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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

Neovascular age-related macular degeneration

Degeneración macular neovascular asociada a la edad.

E.1.1.1

Medical condition in easily understood language

Neovascular age-related macular degeneration

Degeneración macular neovascular asociada a la edad.

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	16.1
E.1.2	Level	LLT
E.1.2	Classification code	10071129
E.1.2	Term	Neovascular age-related macular degeneration
E.1.2	System Organ Class	100000004853

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 establish the safety and tolerability of intravitreous administration of altering regimens of Fovista? (Anti-PDGF-B pegylated aptamer) administered in combination with Anti-VEGF therapy (Lucentis®, Avastin® or Eylea®) in subjects with subfoveal neovascular age-related macular degeneration. . Safety endpoints include adverse events, vital signs, ophthalmic variables [ophthalmic examination, intraocular pressure (IOP), fluorescein angiogram (FA), optical coherence tomography (OCT)], ECG, and laboratory variables.

Evaluar la seguridad y la tolerabilidad de la administración intravítrea de diferentes pautas de Fovista? (aptámero pegilado anti-PDGF-B) y el tratamiento anti-VEGF (Lucentis®, Avastin® o Eylea®) en pacientes con degeneración macular neovascular asociada a la edad. Los criterios de valoración de la seguridad son: acontecimientos adversos, constantes vitales, variables oftalmológicas [examen oftalmológico, presión intraocular (PIO), angiografía con fluoresceína (AF) tomografía de coherencia óptica (OCT)], ECG y variables analíticas.

E.2.2

Secondary objectives of the trial

- Mean change in area of fibrosis as assessed by fibrosis on fundus photography and evaluation of subretinal hyper-reflective material on OCT at 24 months
- Mean number of total combination therapy treatments at 9 months
- Mean change in visual acuity (ETDRS letters) at 9 months

- Cambio medio en la zona de fibrosis según la evaluación de la fibrosis mediante retinografía y según la evaluación del material superreflexivo subretiniano mediante TCO, a los 24 meses
- Número medio de administraciones de tratamiento combinado totales a los 9 meses
- Cambio medio en la agudeza visual (letras ETDRS) a los 9 meses

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Subfoveal choroidal neovascularization (CNV) due to AMD as documented by fluorescein angiogram.
- Best corrected visual acuity in the study eye between 20/40 and 20/400, inclusive. The VA must be re-confirmed at Day 1 prior to randomization.
- Active CNV must compromise at least 25% of the lesion as measured on fluorescein angiogram (including blood, neovascularization, and scar/atrophy)
- Presence on OCT of subretinal, intraretinal or sub-RPE fluid and/or subretinal thickening/reflectivity consistent with active CNV.
- Clear ocular media and adequate pupillary dilatation to allow collection of fundus photographs and fluorescein angiograms of a sufficient quality to be analyzed by the central reading center.
- Intraocular pressure (IOP) of 21 mmHg or less.

- Neovascularización coroidea (NVC) subfoveal debida a DMAE documentada por angiografía con fluoresceína.
- Mejor agudeza visual corregida en el ojo de estudio entre el 20 /40 y 20/400, ambos inclusive. La AV debe ser re-confirmada el Día 1 antes de la aleatorización.
- NVC activas deben comprometer al menos el 25 % de la lesión, medida en angiografía con fluoresceína (incluida la sangre, neovascularización y la cicatriz / atrofia)
- Presencia en la OCT de líquido subretiniano, intraretinal o sub - EPR y / o engrosamiento/ reflectividad subretiniano consistente con NVC activa.
- Medios oculares limpios y adecuada dilatación pupilar para permitir la colección de fotografías del fondo de ojo y angiografía con fluoresceína de una calidad suficiente para ser analizado por el centro de lectura central.
- Presión intraocular (PIO) de 21 mmHg o menos.

E.4

Principal exclusion criteria

- More than 25% of the total lesion size made up of scarring or atrophy. Subjects with subfoveal scar or subfoveal atrophy are excluded.
- More than 50% of the total lesion size consisting of subretinal hemorrhage.
- Presence of retinal angiomatous proliferation (RAP).
- Presence of significant serous pigment epithelial detachments (PEDs), such as large PEDs that constitute greater than 50% of the total lesion or have a vertical height of ? 400 µm.
- Presence of pigment epithelial tears or rips.
- Presence of intraocular inflammation (? trace cell or flare), significant epiretinal membrane (causing distortion of macular anatomy and/or opacification), significant vitreomacular traction (causing distortion of macular anatomy), macular hole or vitreous hemorrhage.
- Aphakia or absence of the posterior capsule. Absence of an intact posterior capsule is allowed if it occurred as a result of YAG laser posterior capsulotomy in association with prior posterior chamber IOL implantation.
- History of idiopathic or autoimmune-associated uveitis in either eye.
- Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, or fundus photography in the study eye. Subjects should not be entered if there is likelihood that they will require cataract surgery in the study eye in the next 12 months.
- Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of -8 diopters or more, or axial length of 25mm or more), the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
- Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication.
- Any ocular or periocular infection in the past twelve (12) weeks.
- History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant.
- Previous therapeutic radiation in the region of the study eye.

- Más de 25 % del tamaño total de la lesión formada por cicatrices o atrofia. Se excluyeron los sujetos con cicatriz subfoveal o atrofia subfoveal.
. Más de 50 % del tamaño total de la lesión que consiste en una hemorragia subretiniana.
- Presencia de proliferación angiomatosa retiniana (RAP).
- Presencia significativa de desprendimientos serosos del epitelio pigmentario (DEPs), tales como grandes DEP que constituyen más del 50 % del total de la lesión o que tienen una altura vertical de ? 400 micras.
- Presencia de desgarros o roturas del epitelio pigmentario.
- Presencia de inflamación intraocular (? célula o turbidez) , membrana epirretiniana significativa (causando distorsión de la anatomía y / o opacificación macular), tracción vitreomacular significativa (causando distorsión de la anatomía macular), agujero macular o hemorragia vítrea.
- Afaquia o ausencia de la cápsula posterior. Se permite la ausencia de una cápsula posterior intacta si se produjo como resultado de capsulotomía posterior con YAG-láser en asociación con LIO de cámara posterior antes de la implantación.
- Historia clínica de uveítis idiopática o autoinmune en cualquiera de los dos ojos.
- Opacidades significativas de medios, incluyendo cataratas, que pueden interferir con la agudeza visual , la evaluación de la toxicidad o fotografía del fondo del ojo del estudio . Los sujetos no deben incluirse si hay probabilidad de que se requiera una cirugía de cataratas en el ojo de estudio en los próximos 12 meses.
- La presencia de otras causas de la neovascularización coroidea, incluyendo la miopía patológica (equivalente esférico de -8 dioptrías o más , o la longitud axial de 25 mm o más ), el síndrome de histoplasmosis ocular, estrías angioides, ruptura coroidea y coroiditis multifocal.
- Cualquier cirugía intraocular o láser térmico dentro de los tres ( 3 ) meses de la inclusión en el ensayo. Cualquier láser térmico previo en la región macular, independientemente de la indicación.
- Cualquier infección ocular o periocular en las últimas doce ( 12) semanas .
- Historia clínica de cualquiera de las siguientes condiciones o procedimientos en el ojo de estudio: el desprendimiento de retina regmatógeno , vitrectomía pars plana , cirugía filtrante (por ejemplo trabeculectomía) , el dispositivo de drenaje para glaucoma , trasplante de córnea.
- Radiación terapéutica previa en la región del ojo de estudio .

E.5 End points

E.5.1

Primary end point(s)

To evaluate the safety, tolerability and development of subfoveal fibrosis by intravitreal administration of altering regimens of FovistaTM (Anti-PDGF-B pegylated aptamer) and Anti-VEGF therapy (Lucentis®, Avastin® or Eylea®) in subjects with neovascular age-related macular degeneration

Evaluar la seguridad, la tolerabilidad y la evolución de la fibrosis subfoveal durante la administración intravítrea de diferentes pautas de Fovista? (aptámero pegilado anti-PDGF-B) y el tratamiento anti-VEGF (Lucentis®, Avastin® o Eylea®) en pacientes con degeneración macular asociada a la edad con neovascularización

E.5.1.1

Timepoint(s) of evaluation of this end point

Following Month 24 visit

Tras la visita del mes 24

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

Following Month 9 and 24 visit

Tras las visitas de mes 9 y 24

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

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

Fovista + Lucentis. Fovista + Avastin. Fovista + Eylea

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

Last visit of the last subject

Ultima visita del ultimo 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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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)

Standard of care

Segun practica clinica

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

2014-04-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-04-03

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

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