Clinical Trials Register

Summary
EudraCT Number:	2012-001699-12
Sponsor's Protocol Code Number:	6078-PG-PSC-193
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:	2012-08-23
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

2012-001699-12

A.3

Full title of the trial

Prospective, open uncontrolled study to evaluate the safety of Depigoid with two pollen combinations ( Grasses/Olea and Grasses/ Parietaria) 2000 DPP/ml in patients with allergic rhinitis or rhinoconjunctivitis with or without seasonal asthma.

Ensayo Clínico prospectivo, abierto, no controlado para evaluar la seguridad de una pauta de escalado rápido de Depigoid con dos combinaciones de pólenes (Gramíneas/Olivo y Gramíneas/Parietaria) 2000DPP/ml en pacientes con rinitis o rinoconjuntivitis alérgica con o sin asma estacional.

A.3.1

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

Safety clinical trial with depigmented and polymerized allergenic extracts of a pollen combination: Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml) or Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml).

Ensayo clínico de seguridad con extractos alergénicos despigmentados y polimerizados de una combinación de pólenes: Depigoid 50% Gramíneas/50% Olea europaea (2000DPP/ml) ó Depigoid 50% Gramíneas/50% Parietaria judaica (2000DPP/ml).

A.4.1

Sponsor's protocol code number

6078-PG-PSC-193

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	Laboratorios LETI, S.L.U
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	Laboratorios LETI, S.L.U
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	Laboratorios LETI, S.L.U
B.5.2	Functional name of contact point	Departamento Médico
B.5.3	Address:
B.5.3.1	Street Address	C/ del Sol, 5
B.5.3.2	Town/ city	Tres Cantos, Madrid
B.5.3.3	Post code	28760
B.5.3.4	Country	Spain
B.5.4	Telephone number	+3491607285953
B.5.5	Fax number	+34918037472
B.5.6	E-mail	mjgomez@leti.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	Depigmented and polymerized allergen extract of 50% Grasses/50% Olea europaea
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Depigmented and polymerized allergen extract of 50% Grasses/50% Olea europaea (2000DPP/ml)
D.3.9.2	Current sponsor code	Depigmented and polymerized allergen extract of 50% Grasses/50% Olea europaea (2000DPP/ml)
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2000
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)	Yes
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	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	Depigmented and polymerized allergen extract of 50% Grasses/50% Parietaria judaica
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Depigmented and polymerized allergen extract of 50% Grasses/50% Parietaria judaica ( 2000DPP/ml)
D.3.9.2	Current sponsor code	Depigmented and polymerized allergen extract of 50% Grasses/50% Parietaria judaica (2000DPP/ml)
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2000
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)	Yes
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

Allergic rhinitis or rhinojunctivitis, with or without seasonal asthma to more than one of the following pollens: Grasses, Olea europaea and Parietaria judaica.

Rinitis o rinoconjuntivitis alérgica, con o sin asma alérgica estacional, por sensibilización a polen de gramíneas y a polen de Olivo o de Parietaria.

E.1.1.1

Medical condition in easily understood language

Allergic rhinitis or rhinoconjunctivitis, with or without seasonal asthma to the following pollens: Grasses, Olea europaea and Parietaria judaica.

Rinitis o rinoconjuntivitis alérgica, con o sin asma bronquial alérgica estacional a más de uno de los siguientes pólenes: Gramíneas, Olea europaea y Parietaria judaica.

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	15.0
E.1.2	Level	LLT
E.1.2	Classification code	10036019
E.1.2	Term	Pollen allergy
E.1.2	System Organ Class	10021428 - Immune 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 this study is to evaluate the safety and tolerance of a rush build up administration of Depigoid forte pollen and the first maintenance dose administered 4 weeks later. The treatment period consists, thus, of 4 weeks.
Primary variable:
?Number of subjects [%] suffering at least one immediate or delayed systemic reaction of grade 2 or higher during the 4-weeks treatment period [grading according to the 2006 EAACI standards;

El objetivo principal de este estudio es evaluar la seguridad y tolerancia de la administración de Depigoid mezcla de polen (Depigoid 50% Gramíneas/50% Olea europaea 2000DPP/ml y Depigoid 50% Gramíneas/50% Parietaria judaica 2000DPP/ml), utilizando una pauta de escalado rápido, y evaluar la seguridad y tolerancia de la primera dosis de mantenimiento, administrado 4 semanas más tarde.

E.2.2

Secondary objectives of the trial

Secondary variables (safety):
?Number of subjects [%] suffering immediate or delayed systemic reactions broken down by grade (EAACI classification).
?Number of subjects [%] suffering immediate or delayed local reactions broken down by diameter (< 5 cm, 5-10 cm or > 10 cm).
?Number of immediate or delayed systemic reactions broken down by grade
(EAACI classification).
?Number of immediate or delayed local reactions broken down by diameter
(< 5 cm, 5-10 cm and > 10 cm).
-(Immunology assessment):
Measurement of the following immunological parameters: sIgE and sIgG4 at baseline and at the end of the study (after two maintenance doses).

Variables secundarias (seguridad):
?Número de sujetos (%) que padecen reacciones sistémicas inmediatas o tardías desglosadas por grado (clasificación de EAACI).
?Número de sujetos (%) que padecen reacciones locales inmediatas o tardías desglosadas por diámetro (< 5 cm, 5-10 cm o > 10 cm).
?Número de reacciones sistémicas inmediatas o tardías desglosadas por grado
(clasificación de EAACI).
?Número de reacciones locales inmediatas o tardías desglosadas por diámetro
(< 5 cm, 5-10 cm y > 10 cm).
Variables secundarias (inmunológicas):
?Respuesta inmunológica medida mediante parámetros inmunológicos (sIgE e sIgG4) tras un dos dosis de mantenimiento comparados con los valores basales antes de iniciar el tratamiento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Subject has dated and signed the informed consent.
-Men and women between 18 and 60 years of age (both inclusive).
-Individuals suffering symptoms of allergic rhinoconjunctivitis or rhinitis during at least the preceding year, with or without allergic seasonal asthma caused by a clinically relevant sensitization to pollens (grasses AND P. judaica or O. europaea). Asthmatic patients can be included in the trial only if seasonal asthma is controlled with a medium daily dose minor or equal to 800 µg/day of budesonide or an equivalent or minor or equal to 400 µg/day of budesonide or an equivalent plus a long-acting-?2 agonist.
- Asthmatic patients must be stable within 3 months prior to Visit 1 and on an stable inhaled steroid dose within 6 weeks prior to visit 1 and throughout the study. FEV1 must be ? 80% of predicted value.
-The IgE-mediated sensitization must be demonstrated by the following: medical history AND IgE specific CAP RAST ? 2 to the suspected relevant pollens (grass pollen AND Olea and/or Parietaria) AND a positive skin prick test to grass and Olea and/or Parietaria.
A skin prick test will be considered positive when it produces a wheal of at least 3 mm according to the largest diameter.

-Pacientes que hayan fechado y firmado el consentimiento informado. .
-Hombres y mujeres con edades comprendidas entre 18 y 60 años (ambas inclusive).
-Pacientes que presenten síntomas clínicamente relevantes de rinitis o rinoconjuntivitis alérgica a lo largo, al menos, del año anterior -con o sin asma alérgica estacional- causada por una sensibilización a polen (gramíneas Y P. judaica u O. europaea). Los pacientes asmáticos pueden participar en el ensayo únicamente cuando el asma estacional esté controlada mediante una dosis diaria media menor o igual a 800 µg/día de budesonida o equivalente o bien menor o igual a 400 µg/día de budesonida o equivalente más un agonista ?2 de acción prolongada.
-Los pacientes asmáticos deben haber permanecido estables durante al menos los 3 meses previos a la visita 1 y con una dosis inhalada de esteroides estable durante las 6 semanas anteriores a la visita 1, además de a lo largo del estudio. El FEV1 debe ser ? 80% del valor teórico.
-La sensibilización mediada por IgE debe demostrarse mediante: el historial médico y una determinación de IgE específica (CAP, etc.) ? 2, para los pólenes que se sospeche puedan ser relevantes (polen de gramínea y de Olea o Parietaria), y una prueba de punción cutánea positiva para gramíneas y Olea o Parietaria2.
Las pruebas de punción cutánea se considerarán positivas cuando produzcan un habón de al menos 3 mm, en su diámetro mayor.

E.4

Principal exclusion criteria

-Any contraindication for treatment with allergen specific immunotherapy.
-Forced expiratory volume in 1 s (FEV1) or peak expiratory flow (PEF) value <80% of the predicted normal value.
-Clinically relevant allergy symptoms due to sensitization to perennial allergens (mites, molds, epithelia) or other seasonal pollen which might interfere with the safety of the IMP.
-Asthma requiring a dose > 800 µg/day of Budesonide or an equilent, without long-lasting beta-2 agonists or requiring a dose > of 400 µg/day of Budesonide or an equivalent plus a long-acting-?2 agonist to reach asthma control, according to the Global Initiative for Asthma (GINA 2010)
-Patients with non controlled bronchial asthma within 3 months prior to Visit 1.
-Patients with asthma who have been treated with systemic steroids within 3 months prior to V1.
-Patients with hospital admission due to asthma exacerbations within 1 year prior to V1.
-Acute or chronic inflammatory or infectious diseases of the airways.
-Chronic structural diseases of the respiratory system (for example, emphysema or bronchiectasis).
-Immune system diseases, both autoimmune diseases and immunodeficiency.
-Any disease involving a contraindication for the use of adrenaline (for example, hyperthyroidism).
-Serious uncontrolled diseases involving a risk for the subjects participating in this study, including the following for example: heart failure, serious or uncontrolled respiratory diseases, endocrine diseases, clinically relevant liver or kidney diseases or hematological diseases.
-Malignant disease with activity in the last 5 years.
-Excessive consumption of alcohol, drugs or medication.
-Serious psychiatric, psychological or neurological disorders.
-Systemic or topical treatment with beta-blocker drugs 1 week before visit 2.
-Treatment with substances interfering with the immune system 2 weeks before visit 2.
-Use of tricyclic, tetracyclic and IMAO antidepressants. It will not be allowed to wash up antidepressants to enter the study because of the risks of interrupting antidepressant treatment, so patients on antidepressants therapy cannot be included in the trial.
-Use of systemic corticosteroids 3 months before visit 1.
-Immunization with prophylactic (bacterial or viral) vaccines within 7 days before visit 1 (prophylactic vaccines are allowed during the administration of IMP period provided they are administered at least one week after IMP administration and the next IMP administration is administered at least 14 days later).
-Participation of the subject in another clinical trial 30 days before visit 2
-Subjects who are going to donate stem cells, blood, organs or bone marrow in the course of the study.
-Female subjects who are pregnant or nursing and women with a positive pregnancy test at visit 1 or 2.
-Women of childbearing potential not using highly effective methods of birth control. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner. Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
-No written informed consent upon enrolment.
-Subjects who are unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study.

-Cualquier contraindicación para tratamiento con inmunoterapia específica de alérgeno, de acuerdo a Position Paper en IT de la EAACI de 2006.
-Valor de volumen espiratorio forzado en 1 s (VEF1) < 80% del valor teórico.
-Síntomas de alergia clínicamente relevantes a causa de la sensibilización a alérgenos perennes (ácaros, mohos, epitelio) u otros pólenes estacionales que puedan interferir en la seguridad del PEI 3
-Asma que requiera dosis > 800 µg/día de budesonida o equivalente, sin agonistas ?2 de acción prolongada, o que requiera dosis > de 400 µg/día de budesonida o equivalente además de un agonista ?2 de acción prolongada para controlar el asma, de acuerdo con la Global Initiative for Asthma (GINA 2010)(54).
-Pacientes con asma bronquial no controlada en el plazo de 3 meses antes de la visita 1.
-Pacientes con asma que se han tratado con esteroides sistémicos en el plazo de 3 meses antes de V1.
-Pacientes que hayan tenido que aumentar la dosis inhalada de esteroides durante las 6 semanas anteriores a la visita 1.
-Pacientes con ingreso hospitalario debido a agravamiento del asma en el plazo de 1 año antes de V1.
-Enfermedades inflamatorias o infecciosas agudas o crónicas en las vías respiratorias.
-Enfermedades estructurales crónicas del sistema respiratorio (por ejemplo, enfisema o bronquiectasia).
-Enfermedades del sistema inmunitario, tanto enfermedades autoinmunes como inmunodeficiencia.
-Cualquier trastorno que contraindique el empleo de adrenalina (por ejemplo, el hipertiroidismo).
-Enfermedades no controladas graves que impliquen un riesgo para los sujetos que participen en este estudio, incluyendo las siguientes: insuficiencia cardiaca, enfermedades neurológicas, enfermedades endocrinológicas, enfermedades hepáticas, renales, vasculares o hematológicas clínicamente relevantes.
-Enfermedad maligna con actividad en los últimos 5 años.
-Consumo excesivo de alcohol, drogas o fármacos en el año anterior.
-Trastornos psiquiátricos o psicológicos clinicamente relevantes.
-Tratamiento sistémico o tópico con fármacos betabloqueantes en la semana previa a la visita 24.
-Tratamiento con sustancias que interfieren con el sistema inmunitario 2 semanas antes de la visita 2.
-Uso de antidepresivos tricíclicos, tetracíclicos o IMAO. No se permitirá la retirada de los antidepresivos para participar en el estudio, a causa del riego que supone interrumpir el tratamiento, por lo que los pacientes tratados con antidepresivos no podrán participar4.
-Uso de corticosteroides sistémicos en los 3 meses previos a la visita 1.
-Inmunización con vacunas profilácticas (bacterianas o virales) en los 7 días anteriores a la visita 1 y en los 7 días anteriores a la visita 2 (las vacunas profilácticas están permitidas durante el período de tratamiento con el PEI siempre que se administren al menos 1 semana después del PEI, y la siguiente administración del PEI se produzca al menos 14 días después de la vacuna).
-Participación del sujeto en otro ensayo clínico 30 días antes de la visita 2.
-Sujetos que van a donar células madre, sangre, órganos o médula ósea en el transcurso del estudio.
-Mujeres que están embarazadas o en periodo de lactancia y mujeres con una prueba de embarazo positiva en la visita 1 ó 2.
-Mujeres que pueden tener hijos que no usen métodos altamente eficaces de control de natalidad. Los métodos altamente eficaces de control de natalidad se definen como los que dan como resultado una baja tasa de fallo (es decir, menos del 1% por año) cuando se usan sistemática y correctamente, tales como implantes, inyectables, anticonceptivos orales combinados, algunos DIU, abstinencia sexual o pareja sometida a vasectomía. Se considerará que las mujeres pueden tener hijos a menos que se hayan sometido a esterilización quirúrgica mediante histerectomía o ligadura de trompas bilateral, o que sean posmenopáusicas durante al menos dos años.
-No firmar el consentimiento informado antes de la inclusión.
-Sujetos que no pueden cumplir con los requisitos del estudio o que en opinión del investigador no deben participar en el estudio.

E.5 End points

E.5.1

Primary end point(s)

The primary variable in this study is the number of subjects [%] who experienced at least one immediate or delayed systemic reaction of grade 2 or higher during the treatment period.

?Número de sujetos (%) que padecen al menos una reacción sistémica inmediata o tardía de grado 2 o superior durante el periodo de tratamiento de 4 semanas (clasificación según los criterios de EAACI de 2006)

E.5.1.1

Timepoint(s) of evaluation of this end point

Safety: Local and systemic adverse reactions (EAACI classification) within 24h after treatment. it must be possible to conduct an extra phone call 48 h after IMP administration provided delayed reactions have occurred within 24 h after IMP administration.

Seguridad: Reacciones adversas locales y sistémicas ( Clasificación EAACI)durante las primeras 24 y 48h tras el tratamiento.

E.5.2

Secondary end point(s)

Secondary variables, which will be analyzed descriptively, are the
?Number of subjects [%] suffering immediate and/or delayed systemic reactions broken down by grade (EAACI classification).
?Number of subjects [%] suffering immediate and/or delayed local reactions broken down by diameter (< 5 cm, 5-10 cm or > 10 cm).
?Number of immediate and/or delayed systemic reactions broken down by grade (EAACI classification).
?Number of immediate and/or delayed local reactions broken down by diameter (< 5 cm, 5-10 cm and > 10 cm).
?(Immunology assessment):Measurement of the following immunological parameters: sIgE and sIgG4 at baseline and at the end of the study (after two maintenance doses).

E.5.2.1

Timepoint(s) of evaluation of this end point

Safety: Local and systemic adverse reactions (EAACI classification) within 24h and 48h after treatment.
Inmunological response: at screening and 1 week after the end of the treatment ( follow-up visit)

Seguridad: Reacciones adversas locales y sistémicas (clasificación EAACI) durante las primeras 24 y 48 horas tras el tratamiento. Respuesta inmunológica: En la visita de selección y 1 semana tras terminar el tratamiento.

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

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Information not present in EudraCT

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)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last visit of the last subject participating in the trial

última visita del último paciente que participa en el ensayo.

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)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

It is not different from the expected normal treatment.

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

2012-10-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-10-11

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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