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    Summary
    EudraCT Number:2013-001308-13
    Sponsor's Protocol Code Number:301-PR-PRI-198
    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:2013-07-12
    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 number2013-001308-13
    A.3Full title of the trial
    Biological standardization of Alternaria alternata allergen extract to
    determine the biological activity in histamine equivalent units (HEP).
    Estandarización biológica del extracto alergénico de Alternaria alternata para determinar la actividad biológica en unidades equivalentes de Histamina (HEP).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To determine the minimum amount of Alternaria alternata allergen
    extract producing a positive skin reaction.
    Determinar la cantidad mínima de extracto alergénico de Alternaria alternata que produce una reacción cutánea positiva.
    A.4.1Sponsor's protocol code number301-PR-PRI-198
    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 SponsorLABORATORIOS LETI S.L.U
    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 supportLABORATORIOS LETI S.L.U
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLABORATORIOS LETI S.L.U
    B.5.2Functional name of contact pointDepartamento Médico
    B.5.3 Address:
    B.5.3.1Street AddressC/ Sol, 5
    B.5.3.2Town/ cityTres Cantos - Madrid
    B.5.3.3Post code28760
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917711742
    B.5.5Fax number+34918037472
    B.5.6E-mailaminano@leti.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 Yes
    D.2.1.1.1Trade name PRICK TEST Alternaria alternata LETI
    D.2.1.1.2Name of the Marketing Authorisation holderLETI pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nativo de Alternaria alternata
    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 INNExtracto alergenico de Alternaria alternata 10 mg/ml
    D.3.9.3Other descriptive nameAllergen Extract
    D.3.9.4EV Substance CodeSUB50983
    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 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) 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 Yes
    D.3.11.13.1Other medicinal product typeProducto para pruebas cutáneas de diagnóstico in vivo
    D.IMP: 2
    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 nameDiclorhidrato de histamina 10 mg/ml
    D.3.2Product code Control positivo
    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 INNDiclorhidrato de histamina 10 mg/ml
    D.3.9.1CAS number 56-92-8
    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 Yes
    D.3.11.13.1Other medicinal product typeSe trata de un control positivo para pruebas cutaneas de diagnostico in vivo.
    D.IMP: 3
    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 nameDiluyente. Solución Salina Fenolada Glicerinada
    D.3.2Product code Control Negativo
    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 INNDiluyente. Solución salina Fenolada Glicerinada
    D.3.9.2Current sponsor codeControl Negativo
    D.3.10 Strength
    D.3.10.1Concentration unit Gtt drop(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Yes
    D.3.11.13.1Other medicinal product typeSe trata de un control negativo para pruebas cutáneas de diagnóstico in vivo.
    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
    Allergy to Alternaria alternata
    Alergia frente a Alternaria alternata
    E.1.1.1Medical condition in easily understood language
    Allergy to Alternaria fungus
    Alergia al hongo Alternaria
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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
    The primary objective is to assess the concentration of alternaria alternata allergen extract that elicits a wheal size equivalent to that of a 10 mg/ml histamine dyhidrochloride solution.
    El objetivo principal consiste en evaluar la concentración de extracto alergénico de Alternaria Alternata que provoca una pápula de un tamaño equivalente a la producida por una solución de dihidroclorhidrato de histamina a 10 mg/ml.
    E.2.2Secondary objectives of the trial
    The secondary objective is to perform the in vitro characterization of the internal
    reference preparation from Subject's serum, to determine their in vitro biological
    potency and to guarantee the consistency of the biological potency of the product batch by batch.
    El objetivo secundario es realizar la caracterización in vitro de dicho PRI a partir del análisis de los sueros de los sujetos, para determinar su potencia biológica in vitro y poder garantizar la consistencia de la potencia biológica del producto lote a lote.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Positive clinical history of inhalatory allergy to Alternaria alternata with (meaning: rhinitis and / or rhinoconjunctivitis and / or asthma)
    -Subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable).
    -Subject can be male or female of any race and ethnic group.
    -Age > and =18 years and < and = 60 years at the study inclusion day.
    -Positive skin prick test with a standardized commercially available preparation of Alternaria alternata allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm or wheal area ? 7 mm2. Positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study
    -A positive test for specific IgE to alternaria alternata (CAP-RAST major or equal to 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.
    -The mean wheal diameters of the obtained with histamine dihydrochloride (10 mg / ml) in the forearm ? 3 mm.
    - Historia clínica positiva de alergia inhalatoria a Alternaria Alternata (es decir rinitis y/o rinoconjuntivitis y/o asma).
    - 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 ? 18 años y ? 60 años en el día de la inclusión en el ensayo.
    - Un prick test positivo con un extracto alergénico estandarizado comercial de Alternaria alternata. El prick test se considerará positivo si el resultado de la prueba cutánea es al menos 3 mm de diámetro medio o área de la pápula ? 7 mm2. Los resultados de la prueba prick-test serán válidos si se realizaron en el año previo a la inclusión del sujeto en el estudio.
    - Una prueba positiva de IgE específica de Alternaria Alternata (CAP-RAST ? 2). Los resultados de la prueba de IgE serán válidos si se realizaron en el año previo a la inclusión del sujeto en el estudio.
    - Síntomas alérgicos durante la estación polínica de Alternaria alternata.
    - La media de los diámetros medios de la pápula obtenida con el dihidroclorhidrato de histamina (10 mg/ml) en el antebrazo ? 3 mm.
    E.4Principal exclusion criteria
    -Immunotherapy in the past 5 years with an allergen preparation known
    to interfere with the allergen to be tested (for example: fungal extracts)
    -Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1 of the protocol.
    -Treatment with any of the following medications: oral tricyclic or tetracyclic antidepressants, beta-blockers, corticosteroids (major 10 mg/daily of prednisone or equivalent).
    - Women who are pregnant or breastfeeding period and women with positive pregnancy test at Visit 1 or 2
    -Dermographism affecting the skin area at the test site at either study visit.
    -Atopic dermatitis affecting the skin area at the test site at either study
    visit.
    -Urticaria affecting the skin area at the test site at either study visit.
    -Diseases of the immune system relevant clinically, both autoimmune and immunodeficiencies.
    -Serious diseases not controlled that may increase the risk for the safety of the subjects involved in this study, including, but not limited to the following: heart failure, uncontrolled or severe respiratory diseases, endocrine diseases, clinically relevant kidney or liver diseases or hematological diseases.
    -Participation in any other clinical trial within 30 days (or 5 times the biological half-life of the research of the study product, whichever is longer) prior to the inclusion of the subject in this clinical trial.
    -Patients with diseases or conditions that limit the use of adrenaline
    (heart disease, severe hypertension, ..)
    -Severe psychiatric, psychological or neurological disorders
    -Abuse of alcohol, drugs or medicines in the previous year.
    -Subjects who have received anti-IgE (Omalizumab).
    -Inmunoterapia en los últimos 5 años con preparaciones alergénicas conocidas que puedan interferir con el alérgeno a testar (por ejemplo: extractos fúngicos).
    -Uso de fármacos que puedan interferir con la respuesta cutánea (por ejemplo: antihistamínicos) dentro de los plazos establecidos en el apéndice 1.
    -Tratamiento con cualquiera de los siguientes medicamentos: antidepresivos tricíclicos o tetracíclicos, betabloqueantes, uso crónico de corticoides orales o uso de corticoides ambos 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 y mujeres con ujna prueba de embarazo positiva en la visita 1 o 2. .
    -Dermografismo que afecte a la zona de la piel en la que se realiza la prueba, en cualquiera de las dos visitas del estudio.
    -Dermatitis atópica que afecte a la zona de la piel en la que se realiza la prueba, en cualquiera de las dos visitas del estudio.
    -Urticaria que afecte a la zona de la piel en la que se realiza la prueba, en cualquiera de las dos visitas del estudio.
    -Enfermedades del sistema inmunitario relevantes clínicamente, tanto autoinmunes como inmunodeficiencias. (Una tiroiditis de Hashimoto con hipotiroidismo bien controlada con tratamiento con hormona tiroidea no supone necesariamente una contraindicación. Una enfermedad de Graves hipertiroidismo) sería criterio de exclusión por el posible riesgo en caso de tener que utilizar adrenalina).
    -Enfermedades graves no controladas que puedan aumentar el riesgo para la seguridad de los sujetos que participen en este estudio, incluyendo, pero no limitando, las siguientes: insuficiencia cardiaca, enfermedades respiratorias graves o no controladas, enfermedades endocrinas, enfermedades hepáticas o renales clínicamente relevantes o enfermedades hematológicas.
    -Participación en cualquier otro ensayo clínico en los 30 días (o 5 veces la semivida biológica del producto en investigación del estudio, lo que sea más largo) previos a la inclusión del sujeto en este ensayo clínico.
    -Sujetos con enfermedades o trastornos que limiten el uso de adrenalina (enfermedades coronarias, HTA grave,etc..)
    -Trastornos psiquiátricos, psicológicos o neurológicos graves.
    -Abuso de alcohol, drogas o medicamentos en el año anterior.
    -Sujetos que hayan recibido tratamiento anti-IgE (Omalizumab).
    E.5 End points
    E.5.1Primary end point(s)
    Wheal size area (mm2) on the skin at the site of the puncture during the
    immediate phase.
    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
    The primary endpoint will be determined after the last patient last visit(end of study).
    La variable principal se determinará tras la UVUP (fin de estudio).
    E.5.2Secondary end point(s)
    The potency of in vitro PRI.
    La potencia del PRI in vitro se determinará mediante la realización de inmunoensayos
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secundary endpoint will be determined after the last patient last visit (end of study).
    La variable secundaria se determinará tras la UVUP (fin de estudio).
    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 Yes
    E.8.1.7.1Other trial design description
    Los parametros de control estarán siempre incluidos en cada uno de los sujetos
    Control parametres are allways included in each of the subjects
    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, Diclorhidrato de Histamina y Control negativo (solución salina)
    Positive Control 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 concerned2
    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
    Ultima 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 months9
    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: 30
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-07-12. Yes
    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 state30
    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)
    The clinical trial is on the diagnosis of Alternaria alternata prick test.
    This section does not apply because of the characteristics of the study (patients do not
    receive treatment).
    El ensayo clínico es sobre el prick diagnostico de Alternaria alternata.
    Esta sección no aplica debido a las características del estudio(los pacientes no reciben
    tratamiento).
    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 Decision2013-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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