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    Summary
    EudraCT Number:2011-000460-10
    Sponsor's Protocol Code Number:EMR200104_010
    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:2011-06-21
    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 number2011-000460-10
    A.3Full title of the trial
    First year growth response associated genetic
    markers validation Phase IV open-label study in
    Growth Hormone Deficient and Turner Syndrome
    pre-pubertal children : the PREDICT
    Pharmacogenetics Validation Study
    Estudio abierto en Fase IV de validación de los marcadores
    genéticos asociados con la respuesta del crecimiento del primer año en niños prepúberes con déficit de hormona de crecimiento y síndrome de Turner: Estudio de validación PGx PREDICT
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patients
    Estudio de validación de marcadores genéticos para el tratamiento de hormona de crecimiento en pacientes con deficit de hormona de creciminiento y sindrome de Turner.
    A.3.2Name or abbreviated title of the trial where available
    PREDICT PGx Validation Study
    Estudio de validación PGx PREDICT
    A.4.1Sponsor's protocol code numberEMR200104_010
    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 SponsorMerck Serono S.A. Geneva
    B.1.3.4CountrySwitzerland
    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 supportMerck Serono S.A. Geneva
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Center Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Strasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number496151725200
    B.5.5Fax number496151722000
    B.5.6E-mailservice@merck.de
    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 Saizen 8mg click.easy power for solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderSerono Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameNA
    D.3.2Product code NA
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsomatropin
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameRECOMBINANT HUMAN GROWTH HORMONE
    D.3.9.4EV Substance CodeSUB20678
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.83
    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 Yes
    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
    Idiopathic Growth Hormone Deficiency and
    Turner Syndrome
    Deficit de Hormona del Crecimiento Idiopático y Síndrome de Turner.
    E.1.1.1Medical condition in easily understood language
    Patients having a growth hormone deficiency or Turner Syndrome
    Pacientes con deficit de hormona de crecimiento o sindrome de Turner.
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10056438
    E.1.2Term Growth hormone deficiency
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10045181
    E.1.2Term Turner's syndrome
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic 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 that at least one of the genetic markers associated to the
    amplitude of first year growth response to recombinant human
    growth hormone (r-hGH) treatment identified in PREDICT Long-
    Term Follow-Up (LTFU) Study (28614) is replicated in an
    independent population of this study of prepubertal children with
    either idiopathic growth hormone deficiency (IGHD) or Turner
    Syndrome (TS).
    Confirmar que al menos uno de los marcadores genéticos relacionados con la amplitud de la respuesta del crecimiento del primer año al tratamiento con hormona de crecimiento humana recombinante
    (r-hGH) identificados en el estudio de seguimiento a largo plazo PREDICT (LTFU) (28614), se replica en una población independiente de este estudio, de niños prepúberes con déficit idiopático de
    hormona de crecimiento (IGHD) o síndrome de Turner (TS).
    E.2.2Secondary objectives of the trial
    To evaluate the contribution of validated genetic markers related
    to the amplitude of first year growth in IGHD children in
    response to r-hGH therapy using a model derived from the
    growth hormone deficiency (GHD) Kabi-Pharmacia
    International Growth Study (KIGS) predictive model of the first
    year growth response to r-hGH.
    To evaluate the contribution of validated genetic markers related
    to the amplitude of first year growth in TS girls in response to rhGH
    therapy in TS girls using a model derived from the TS
    KIGS predictive model of the first year growth response to r-hGH.
    Evaluar la contribución de marcadores genéticos validados asociados con la amplitud del crecimiento
    del primer año como respuesta a la terapia con r-hGH en niños con IGHD, mediante un modelo
    derivado del modelo predictivo de la respuesta del crecimiento del primer año a la r hGH del estudio
    internacional del déficit de hormona de crecimiento (GHD) de Kabi-Pharmacia (KIGS). Evaluar la
    contribución de marcadores genéticos validados asociados con la amplitud del crecimiento del primer año como respuesta a la terapia con r-hGH en niñas con TS, mediante un modelo derivado del modelo predictivo de la respuesta del crecimiento del primer año a la r-hGH para el TS del KIGS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pre-established diagnosis of IGHD or TS based on classical criteria
    with at least 1 year of r-hGH therapy and with Tanner stage 1 at
    treatment start
    Retrospective availability of a complete set of clinical, auxological
    and biological parameters necessary for building the predictive
    model
    Diagnóstico preestablecido de IGHD o TS, basado en criterios clásicos, con al menos 1 año de terapia
    con r-hGH, y estadio 1 de Tanner al inicio del tratamiento Disponibilidad retrospectiva de una serie
    completa de los parámetros clínicos, auxológicos y biológicos, necesarios para construir el modelo
    predictivo
    E.4Principal exclusion criteria
    Acquired GHD
    Any drug or disease that could affect growth
    GHD adquirido.
    Cualquier fármaco o patología que pueda afectar al crecimiento
    E.5 End points
    E.5.1Primary end point(s)
    The list of genetic markers associated to the first
    year growth response to r-hGH measured by the 3 following growth
    parameters:
    Change from baseline to year 1 in Height (cm)
    Change from baseline to year 1 in Height standard deviation score
    (SDS)
    Height Velocity (HV) (cm/year) SDS at 1 year
    La lista de marcadores genéticos asociados con la respuesta del crecimiento del primer año a la r-hGH, determinada a partir de los 3 parámetros del crecimiento siguientes: Cambio desde el periodo basal hasta el año 1 en la talla (cm) Cambio desde el periodo basal hasta el año 1en la puntuación de la desviación estándar de la talla (SDS) SDS de la velocidad de crecimiento (HV) (cm/año) al cabo de 1 año
    E.5.1.1Timepoint(s) of evaluation of this end point
    at time of final report
    En el momento del informe final
    E.5.2Secondary end point(s)
    The first year growth predictive value of the models including the
    validated genetic markers on HV (cm/year) at 1 year in IGHD
    children and in TS girls treated with r-hGH combined to wellestablished
    clinical, auxological and biological markers derived
    from the KIGS GHD predictive model of the first year growth
    response to r-hGH therapy
    Evaluar la contribución de marcadores genéticos validados
    asociados con la amplitud del crecimiento del primer año como
    respuesta a la terapia con r-hGH en niños con IGHD, mediante
    un modelo derivado del modelo predictivo de la respuesta del
    crecimiento del primer año a la r-hGH del estudio internacional
    del déficit de hormona de crecimiento (GHD) de Kabi-
    Pharmacia (KIGS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    at time of final report
    En el momento del informe final
    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 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 No
    E.6.10Pharmacogenetic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Canada
    Czech Republic
    France
    Italy
    Spain
    United Kingdom
    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 years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 350
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 175
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 175
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 45
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    paediatric patients
    Pacientes pediatricos.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 395
    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)
    non IMP trial
    Ensayo sin Medicamento en Investigación
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-03
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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