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    Summary
    EudraCT Number:2014-001210-26
    Sponsor's Protocol Code Number:PRO-VB-GRA-03
    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:2015-05-06
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-001210-26
    A.3Full title of the trial
    Biological standardization of allergen extracts of pollen of Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense and Poa pratensis in patients sensitized to them.
    Estandarización biológica in vivo de los extractos alergénicos del polen de Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense y Poa pratensis en pacientes sensibilizados a los mismos.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Biological standardization of allergen extracts of pollen of Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense and Poa pratensis in patients sensitized to them.
    Estandarización biológica in vivo de los extractos alergénicos del polen de Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense y Poa pratensis en pacientes sensibilizados a los mismos.
    A.4.1Sponsor's protocol code numberPRO-VB-GRA-03
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPROBELTE PHARMA S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPROBELTE PHARMA S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPROBELTE PHARMA S.A.
    B.5.2Functional name of contact pointMedical Deparment
    B.5.3 Address:
    B.5.3.1Street AddressCalle Antonio Belmonte Abellán 3-7
    B.5.3.2Town/ cityMurcia
    B.5.3.3Post code30100
    B.5.3.4CountrySpain
    B.5.4Telephone number+34968 858 577
    B.5.5Fax number+34968 307 498
    B.5.6E-mailanamartinez@probeltepharma.es
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameExtracto alergénico de polen de Dactylis glomerata
    D.3.4Pharmaceutical form Solution for skin-prick test
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDACTYLIS GLOMERATA POLLEN EXTRACT
    D.3.9.3Other descriptive nameDACTYLIS GLOMERATA POLLEN EXTRACT
    D.3.9.4EV Substance CodeSUB84568
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.01 to 10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameExtracto alergénico de polen de Festuca pratensis
    D.3.4Pharmaceutical form Solution for skin-prick test
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFESTUCA PRATENSIS POLLEN
    D.3.9.3Other descriptive nameFESTUCA PRATENSIS POLLEN
    D.3.9.4EV Substance CodeSUB35800
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.01 to 10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameExtracto alergénico de polen de Lolium perenne
    D.3.4Pharmaceutical form Solution for skin-prick test
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLOLIUM PERENNE POLLEN EXTRACT
    D.3.9.3Other descriptive nameLOLIUM PERENNE POLLEN EXTRACT
    D.3.9.4EV Substance CodeSUB84560
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.01 to 10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameExtracto alergénico de polen de Phleum pratense
    D.3.4Pharmaceutical form Solution for skin-prick test
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPHLEUM PRATENSE POLLEN
    D.3.9.3Other descriptive namePHLEUM PRATENSE POLLEN
    D.3.9.4EV Substance CodeSUB35149
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.01 to 10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 5
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameExtracto alergénico de polen de Poa pratensis
    D.3.4Pharmaceutical form Solution for skin-prick test
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOA PRATENSIS POLLEN EXTRACT
    D.3.9.3Other descriptive namePOA PRATENSIS POLLEN EXTRACT
    D.3.9.4EV Substance CodeSUB84562
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.01 to 10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 6
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDICLOROHIDRATO HISTAMINA 10 mg/ml
    D.3.2Product code Control positivo
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHISTAMINE DIHYDROCHLORIDE
    D.3.9.3Other descriptive nameHISTAMINE DIHYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB12022MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another 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.1.1Medical condition(s) being investigated
    Biological standardization for allergenic extracts in patients with
    hipersensibility to extracts.
    Estandarización biológica de extractos alergénicos en pacientes con
    hipersensibilidad a los extractos.
    E.1.1.1Medical condition in easily understood language
    Biological standardization for allergenic extracts in patients with
    hipersensibility to extracts.
    Estandarización biológica de extractos alergénicos en pacientes con
    hipersensibilidad a los extractos.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In vivo determination of biological activity of the extracts of grass pollen, Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense and Poa pratensis.
    Determinación in vivo de la actividad biológica de los extractos de polen de Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense y Poa pratensis.
    E.2.2Secondary objectives of the trial
    Determinate the concentration of allergen extract which causes a wheal with equivalent size to that produced by a solution of 10mg/ml Histamine.
    Determinar la concentración de extracto alergénico que provoca una pápula de un tamaño equivalente a la producida por una solución de Histamina de 10mg/ml.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Positive clinical history of allergy inhalation (rhinitis and / or rhinoconjunctivitis and / or asthma) against allergen extract.
    - Signed written informed consent.
    - Subjects of both sexes, of every race and ethnicity.
    - Age between18-60 years old.
    - A positive prick test (diameter of the wheal greater or equal than 3 mm) with a standardized allergen extract commercial
    - A positive test for specific IgE of the allergen extract in class 3 or higher blood serum
    - Patients must live in a geographic area where the allergy caused by the allergen in question is a relevant problem.
    - Historia clínica positiva de alergia inhalatoria (rinitis y/o rinoconjuntivitis y/o asma) frente al extracto alergénico.
    - El sujeto (y/o su representante legal, si procede) ha otorgado su consentimiento informado por escrito, y lo ha firmado y fechado debidamente.
    - Sujetos de ambos sexos, de cualquier raza y grupo étnico.
    - Edad entre 18 años y 60 años en el día de la inclusión en el ensayo.
    - Un prick test positivo (diámetro medio de la pápula mayor o igual a 3mm) con un extracto alergénico estandarizado comercial.
    - Una prueba positiva de IgE específica del extracto alergénico en suero de clase 3 o superior.
    - Los pacientes deben vivir en un área geográfica donde la alergia causada por el alérgeno en cuestión sea un problema relevante.
    E.4Principal exclusion criteria
    -Allergen immunotheraphy in the last 5 years with a Grass pollen extract .
    -Drugs that may interfere the cutaneous response 15 days before the study and during the study (eg, antihistamines).
    -Patients who had received treatments with: blockers, tetraciclic or tryciclic antidepresives, IMAOS, corticosteroids chronic use of oral corticosteroids, or corticosteroids use orally or parenterally in repeated and intermittent regimens (> 10 mg / day of prednisone or equivalent).
    -Pregnant or lactating women
    - Dermographism, atopic dermatitis and / or urticaria that affects the skin area where the test is performed.
    -Clinically relevant immune system diseases, both autoimmune and immunodeficiency
    -Serious uncontrolled illness that may increase the risk to the safety of the subjects participating in this study
    -Subjects with diseases or conditions that limit the use of adrenaline (coronary heart disease, severe hypertension, etc..).
    -Subjects who have received anti-IgE treatment (Omalizumab).
    - Inmunoterapia en los últimos 5 años con un extracto alergénico de gramíneas espontáneas u otros extractos alergénicos que puedan interferir con el alérgeno a testar por presentar un alto grado de reactividad cruzada.
    - Uso de fármacos que puedan interferir con la respuesta cutánea 15 días antes del estudio y durante el estudio (por ejemplo: antihistamínicos).
    - Tratamiento con cualquiera de los siguientes medicamentos: antidepresivos tricíclicos, tetracíclicos o IMAOs, betabloqueantes, uso crónico de corticoides orales, o uso de corticoides vía oral o parenteral en pautas repetidas e intermitentes (> 10 mg/día de prednisona o equivalente).
    - Mujeres que estén embarazadas o en periodo de lactancia.
    - Dermografismo, Dermatitis Atópica y/o Urticaria que afecte a la zona de la piel en la que se realiza la prueba.
    - Enfermedades del sistema inmunitario relevantes clínicamente, tanto autoinmunes como inmunodeficiencias.
    - Enfermedades graves no controladas que puedan aumentar el riesgo para la seguridad de los sujetos que participen en este estudio.
    - Sujetos con enfermedades o trastornos que limiten el uso de adrenalina (enfermedades coronarias, HTA grave, etc.).
    - Sujetos que hayan recibido tratamiento anti-IgE (Omalizumab).
    E.5 End points
    E.5.1Primary end point(s)
    The wheal size area (mm2) which is produced on the skin after the extract application
    El área de la pápula (mm2)que se produce en la piel después de la aplicación del extracto
    E.5.1.1Timepoint(s) of evaluation of this end point
    15 minutes after prick test
    15 minutos después del prick test
    E.5.2Secondary end point(s)
    N/A
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Control positivo (Histamina Diclorhidrato) y Control Negativo (solución salina)
    Positive and negative control
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 63
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state63
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-05-02
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