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    The EU Clinical Trials Register currently displays   38489   clinical trials with a EudraCT protocol, of which   6324   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-004429-42
    Sponsor's Protocol Code Number:DIA-Der-02-14
    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:2014-12-16
    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 number2014-004429-42
    A.3Full title of the trial
    Open multicenter clinical trial to confirm the maximum no reactive dose of allergoid of polymerized Dermatophagoides pteronyssinus, in patients with allergic rhinoconjunctivitis or mild or moderate ashtma, who are sensitive to Dermatophagoides pteronyssinus
    Ensayo clínico multicéntrico y abierto, para la confirmación de la dosis máxima no reactiva (titulación a punto final) con el alergoide Dermatophagoides pteronyssinus polimerizado administrado por vía intradérmica, en pacientes con rinoconjuntivitis alérgica o asma leve o moderado, sensibilizados al ácaro Dermatophagoides pteronyssinus.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter clinical trial with several doses of polymerized Dermatophagoides pteronyssinus to confirm the dose that does not produce a local reaction in the administration area, in patients with allergy to Dermatophagoides pteronyssinus
    Estudio clínico multicéntrico con varias dosis de Dermatophagoides
    pteronyssinus polimerizado para confirmar la dosis que no produce
    reacción local en la zona de administración, en pacientes alérgicos a los
    ácaros de la especie Dermatophagoides pteronyssinus
    A.4.1Sponsor's protocol code numberDIA-Der-02-14
    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 SponsorDiater Laboratorio de Diagnósticos y Aplicaciones Terapéuticas, 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 supportDiater Laboratorio de Diagnósticos y Aplicaciones Terapéuticas, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDiater Laboratorio de Diagnósticos y Aplicaciones Terapéuticas, S.A.
    B.5.2Functional name of contact pointClinical Trial Departament
    B.5.3 Address:
    B.5.3.1Street Addressavenida Gregorio Peces Barba, 2, Parque Tecnologico de Leganes
    B.5.3.2Town/ cityLeganes, Madrid
    B.5.3.3Post code28918
    B.5.3.4CountrySpain
    B.5.4Telephone number0034914966013
    B.5.5Fax number0034914966012
    B.5.6E-mailj.campos@diater.com
    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 namePolymerized Dermatophagoides pteronyssinus
    D.3.2Product code Der p pol
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPolymerized Dermatophagoides pteronyssinus
    D.3.9.3Other descriptive nameDERMATOPHAGOIDES PTERONYSSINUS, DEPIGMENTED/POLYMERIZED EXTRACT
    D.3.9.4EV Substance CodeSUB84529
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number0.1
    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.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
    Allergic patients to Dermatophagoides pteronyssinus, with
    rhinoconjunctivitis or mild or moderate asthma
    Pacientes alergicos a Dermatophagoides pteronyssinus con rinoconjuntivitis o asma leve o moderado
    E.1.1.1Medical condition in easily understood language
    Allergic patients to Dermatophagoides pteronyssinus, with
    rhinoconjunctivitis or mild or moderate asthma
    Pacientes alergicos a Dermatophagoides pteronyssinus con rinoconjuntivitis o asma leve o moderado
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10057631
    E.1.2Term House dust allergy
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To confirm the maximum no reactive dose of Polymerized Dermatophagoides pteronyssinus, administered intradermally
    Confirmar la dosis máxima no reactiva del Dermatophagoides pteronyssinus polimerizado administrado por vía intradermica
    E.2.2Secondary objectives of the trial
    - Safety assessment
    - Maximum erythema diameter
    - Immunological biomarkers in blood sample
    - Evaluación de la seguridad
    - Diametro mayor de eritema
    - Determinación de inmunoglobulinas en muestra de sangre
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age >=18 and <=60 years old.
    2. Patients that signed the informed consent to partipate in the study.
    3. Sensitive patients to Dermatophagoides pteronyssinus, demonstrated
    by: Specific IgE >= 3.5 KU/L (CAP) in the year previous to the study;
    Positive Prick test
    4. Clinical symptoms of rhinitis or rhinoconjunctivitis or mildr
    moderate ashtma.
    5. Patients able to fulfill the treatment.
    6. Women must have negative results in pregancy test. Pregnancy test
    must be done 7 days before the start of the study.
    7. Only patients that the investigator considers that are stable for their
    allergy for the last six months could be participate in the study
    1. Pacientes con edades comprendidas entre los ?18 y ?60 años.
    2. Paciente que haya otorgado su consentimiento informado para participar en el estudio.
    3. Demostración de sensibilidad a la fuente alergénica y alérgenos mayores:
    Presencia de IgE específica: 3.5 KU/l (FEIA) en el año anterior previo a la administración de la primera dosis del estudio: pruebas cutáneas alérgeno?específicas positivas.
    4. Demostración clínica de patología concordante con cuadros de rinitis o rinoconjuntivitis o asma leve o moderado controlado.
    5. Paciente capaz de cumplir con el tratamiento.
    6. Las mujeres en edad fértil deben presentar una prueba de embarazo en orina con resultado negativo en los 7 días previos a la inclusión en el ensayo.
    7. Pacientes que responda a los criterios anteriores y que considere el investigador que se ha mantenido estable respecto a su enfermedad alérgica durante los 6 meses previos a la entrada en el estudio.
    E.4Principal exclusion criteria
    1. Patients with concomitant inmune alterations.
    2. Poli-sensitized allergic patients to relevant allergens or no-controlled
    allergens.
    3. Patients that received inmunotherapy against Dermatophagoides
    pteronyssinus in the last 3 years.
    4. Patients with serious or persistent asthma
    5. Malign diseases
    6. Patients with cardiovascular diseases that could get worse after
    adrenalin administration
    7. Active tuberculosis
    8. Serious atopic eczema
    9. Patients under betablockers treatment
    10. Patients who decide not further to colaborate in trial
    11. Pregnant or breastfeeding women
    12. Severe episodes needed of hospital care related to asthma, or
    systemic steroid administration in the three months previous to the start
    of the assay.
    13. Patients simultaneously participating in another clinical trial
    14. Any other pathology that interfiere with the inmune response.
    15. Chronic abuse of alcohol or other substances.
    1. Enfermedades inmunológicas coexistentes.
    2. Pacientes polisensibilizados que lo sean a alérgenos relevantes y no controlados.
    3. Pacientes que hayan recibido inmunoterapia a ácaros en los 3 años previos al comienzo del ensayo.
    4. Pacientes con asma grave o no controlado.
    5. Enfermedades malignas.
    6. Trastornos cardiovasculares, que puedan ser agravados por el uso de adrenalina.
    7. Tuberculosis activa.
    8. Eczema atópico severo.
    9. Pacientes en tratamiento con betabloqueantes.
    10. Pacientes que decidan interrumpir su colaboración en el estudio.
    11. Mujeres embarazadas o en periodos de lactancia.
    12. Presencia de exacerbaciones severas, que hayan precisado de atención en urgencias o ingresos por asma, así como de administración de esteroides sistémicos en los 3 meses previos a la selección.
    13. Participación simultánea en otros ensayos clínicos.
    14. Cualquier enfermedad que interfiera en la respuesta inmune.
    15. Abuso crónico de alcohol o algún otro tipo de sustancia.
    E.5 End points
    E.5.1Primary end point(s)
    - Maximum wheal diameter
    - Diametro mayor de pápula
    E.5.1.1Timepoint(s) of evaluation of this end point
    At time 0 and 15 minutes after treatment administration
    A tiempo 0 y 15 minutos trás la administración
    E.5.2Secondary end point(s)
    - Safety assessment: record and follow-up of Adverse Reaction
    - Maximun erythema diameter
    - Immunological bimarkers in blood samples: specific der p 1 and der p 2 IgE and IgG4
    - Evaluación de la seguridad: Documentación y seguimiento de las Reacciones Adversas
    - Medición de diámetro mayor de eritema
    - Inmunoglobulinas: IgE e IgG4 der p 1 y der p 2 especificas
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Safety assessment: along the study
    - Maximun erythema diameter: 15 minutes after administration
    - Immunological bimarkers: before and after the treatment
    - Evaluación de la seguridad: durante todo el ensayo
    - Medición de diámetro mayor de eritema: a los 15 minutos tras la administración
    - Inmunoglobulinas: antes y después del tratamiento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    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 No
    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 No
    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 concerned4
    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
    LVLS
    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 months5
    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: 40
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    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)
    Patients could participate in next clinical trials
    Los pacientes podrán participar en los ensayos siguientes
    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 Decision2015-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-04
    P. End of Trial
    P.End of Trial StatusCompleted
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