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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-000563-41
    Sponsor's Protocol Code Number:IMIMFTCL/GH/4
    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:2014-06-13
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-000563-41
    A.3Full title of the trial
    Recombinant hGH Biomarkers Discovery
    Estudio de biomarcadores indicativos de la exposición a hormona de crecimiento recombinante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ?Recombinant hGH Biomarkers Discovery?
    Estudio de biomarcadores indicativos de la exposición a hormona de crecimiento recombinante
    A.3.2Name or abbreviated title of the trial where available
    REBIODIS
    REBIODIS
    A.4.1Sponsor's protocol code numberIMIMFTCL/GH/4
    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 SponsorConsorci Mar Parc de Salut de Barcelona (Parc de Salut Mar)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportWorld Anti-doping Agency
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital del Mar Research Institute (IMIM)
    B.5.2Functional name of contact pointHuman Pharmacology reseach group
    B.5.3 Address:
    B.5.3.1Street AddressDoctor Aiguader 88
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08003
    B.5.3.4CountrySpain
    B.5.4Telephone number+0034933160490
    B.5.5Fax number+0034933160479
    B.5.6E-mailmfarre@imim.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 Yes
    D.2.1.1.1Trade name NutropinAq
    D.2.1.1.2Name of the Marketing Authorisation holderGenentech, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameNutropinAq
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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.3.9.3Other descriptive nameSOMATROPIN FOR INJECTION
    D.3.9.4EV Substance CodeSUB12322MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.016 to 0.066
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled pen
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthy volunteers. There is not intended indication.
    Este estudio se realizará en voluntarios sanos sin ninguna patología concurrente.
    E.1.1.1Medical condition in easily understood language
    Not applicable
    No aplica
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
    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 collection of biological samples positive to somatropin in the context of a controlled clinical trial study for their further use for the evaluation of biomarkers of recombinant growth hormone misuse in humans.
    La generación de muestras biológicas positivas a somatropina en el contexto de un ensayo clínico controlado, para la evaluación de los biomarcadores de esta hormona que permiten detectar el abuso de esta sustancia en personas sanas.
    E.2.2Secondary objectives of the trial
    Primary Objectives:
    - To demonstrate that concentrations of biomarkers in blood change in a dose dependent manner with the exposure to rhGH.
    - To explore the time window in which changes in biomarkers may be detected after hrGH exposure

    Secondary Objectives:
    - To evaluate potential gender differences
    - To evaluate potential interethnic differences
    Objetivos principales:
    - Demostrar que las concentraciones de biomarcadores en sangre de rhGH es dosis-dependiente.
    - Conocer los intervalos de tiempo en los que pueden detectarse los biomarcadores de rhGH tras su administración.

    Objetivos secundarios:
    - Evaluar las diferencias entre géneros.
    - Evaluar las diferencias interétnicas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Healthy male and females volunteers aged from 18 to 30 years, both ages included.
    - Caucasian and non-Caucasian individuals (Europeans, Africans, Asians, Indians).
    - Body mass index (BMI) between 19 and 26 Kg/m2, and weight between 50 and 90 kg.
    - Subjects with high level of physical training including regular high-resistance strength training, training at least 5 hours a week or an expenditure of energy of about 5000 kcal a week.
    - A health profile devoid of organic or physiological disorders.
    - Pass the review based on medical history, physical examination and clinical laboratory tests.
    - Understand and accept the trial procedures.
    - Signature of the written informed consent to participate.
    - Individuos (hombres y mujeres) de 18 a 40 años, ambas edades incluidas.
    - Individuos caucásicos (europeos) y no caucásicos (de origen africano, asiático, indio).
    - Índice de masa corporal (IMC: peso/altura2) de cada participante entre 19 y 26 y peso entre 50 y 90 kg.
    - Deportistas que realicen actividad física moderada-intensa al menos 5 horas a la semana, o que realicen un gasto energético de aproximadamente 5.000 kcal a la semana en la práctica deportiva.
    - Historial y examen físico que demuestren no presentar trastornos orgánicos o psiquiátricos.
    - Pasar una revisión médica basada en la historia clínica, examen físico y pruebas de laboratorio clínico.
    - Comprender y aceptar los procedimientos del ensayo.
    - Firma del consentimiento informado.
    E.4Principal exclusion criteria
    - Non compliance of the inclusion criteria.
    - Prior or current history of consumption of addictive substances (except nicotine). Smokers of more than 10 cigarettes / day should be excluded.
    Have some organic disease or major surgery in the 3 months prior to the start the study.
    - Suffer any kind of disease, acute or chronic, at the moment of the study.
    - Regular consumers of medications that contain any of the following substances: steroids, erythropoietin (EPO), growth hormone (hGH), insulin-like growth factor-1 (IGF-1), diuretics and plasma expanders. Intake of beta blockers and glucocorticoids in asthmatics is accepted. Other medication will be accepted depending on the Principal Investigator criteria, as flu containing ephedrines.
    - A prior history of or presence of significant cardiovascular, neurological, haematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease or other condition known to interfere with absorption, distribution, metabolism, or excretion of the drug administered in the study. If the subjects will be at risk as decided by the Investigator.
    - Suffer any kind of bone or connective tissues injuries in the last 3 months.
    - A significant psychiatric disorder, alcoholism, substance abuse or dependence (except for nicotine, criteria defined above), or consumption of psychoactive drugs.
    - Alcohol consumption over 15 grams per day in men and 10 grams per day in women.
    - Caffeine or another drinks specified like drinking > 3 cups of coffee and tea per day, drinking > 3 units of coke, stimulants or equivalent per day, in the 2 months prior to the study.
    - Have used a medication regularly in the last month previous to the start of the study. Other type of medication may be allowed, depending on the Investigator.
    - To be blood donor or have taken part in studies with blood donation in the last 4 weeks prior to the study.
    - History of allergy or adverse reactions to any medication.
    - Have been a volunteer in another study with drugs in the last 3 months prior to start this study.
    - Subjects for whom the drug involved in the study is counter indicated.
    - Subjects with positive serology for hepatitis B, C or HIV.
    - Women with pregnancy or in the breast-feeding period or that are taking contraception treatment during the period of the study.
    - Subjects that not have capacity to understand the nature, consequences of the study or the procedures requested to follow.
    - No cumplir con los criterios de inclusión.
    - Sujetos con historia previa o actual de dependencia de sustancias de adicción (excepto nicotina). En este sentido, los consumidores de más de 10 cigarrillos/día serán excluidos.
    - Haber padecido alguna enfermedad orgánica o cirugía mayor durante los tres meses anteriores al ensayo.
    - Padecer cualquier tipo de enfermedad, aguda o crónica en el momento del estudio.
    - Consumidores habituales de medicamentos de venta libre en farmacia que contengan alguna de las siguientes sustancias: esteroides, eritropoyetina (EPO), hormona de crecimiento (hGH), factor de crecimiento insulínico tipo 1 (IGF-1), diuréticos y expansores del plasma. Se acepta la ingesta de betabloqueantes y glucocorticoides en personas asmáticas. Otro tipo de medicación será admitida a criterio del investigador, como los medicamentos que contienen efedrinas, en el tratamiento de la gripe.
    - Antecedentes o evidencia clínica de patología cardiovascular, respiratoria, renal, hepática, endocrina, gastrointestinal, hematológica, neurológica, dermatológicas, u otras enfermedades agudas o crónicas que, a juicio del Investigador Principal o los colaboradores designados por éste, puedan suponer un riesgo para los sujetos o interferir en los objetivos del estudio o que puedan hacer sospechar una alteración de la absorción, distribución, metabolismo o excreción del fármaco.
    - Haber padecido algún tipo de lesión ósea o de ligamentos en los últimos tres meses.
    - Antecedentes o evidencia clínica de trastornos psiquiátricos, alcoholismo, abuso de fármacos u otras drogas o consumo habitual de fármacos o sustancias psicoactivas.
    - Consumo de alcohol superior a 15 g/día en hombres y 10 g/día en mujeres.
    - Consumidores de o bien 3 tazas de café y té al día, consumidores de más de 3 unidades de cola u otras bebidas estimulantes o equivalentes al día, en el mes previo al inicio del estudio.
    - Ingesta regular de medicación en el mes que precede al estudio. Otro tipo de medicación será admitida a criterio del Investigador.
    - Haber donado sangre o participado en estudios en los que haya extracciones de sangre en las 4 semanas anteriores.
    - Antecedentes de alergia, idiosincrasia, hipersensibilidad o reacciones adversas al principio activo o cualquiera de los excipientes. Reacciones adversas graves a medicamentos.
    - Haber participado en otro ensayo clínico con medicamentos en los tres meses previos al inicio del estudio.
    - Sujetos con contraindicaciones al tratamiento con el fármaco de estudio (según la ficha técnica).
    - Sujetos con serología positiva a hepatitis B, C y VIH.
    - Mujeres embarazadas o en período de lactancia, o que tomen contraceptivos orales en el momento del estudio.
    - Sujetos que no sean capaces de entender la naturaleza, consecuencias del ensayo y los procedimientos que se les solicita seguir.
    E.5 End points
    E.5.1Primary end point(s)
    Blood concentration of growth hormone biomarkers that reflect the activity of the growth hormone misuse in humans. Moreover, It will be assessed the pharmacokinetics and the bio-availability of the growth hormone.
    Concentraciones en sangre de los biomarcadores moleculares de la hormona de crecimiento que reflejan la administración exógena de la hormona en personas sanas. Además, se valorará la farmacocinética y la biodisponibilidad de la somatropina.
    E.5.1.1Timepoint(s) of evaluation of this end point
    20 days during 15 weeks period of evaluation of the growth hormone biomarkers
    20 días no consecutivos de análisis de biomarcadores de la hormona de crecimiento, durante un periodo de 15 semanas.
    E.5.2Secondary end point(s)
    Drugs safety and tolerability
    Seguridad y tolerabilidad del fármaco empleado.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From day 1 to 21 (both included) of somatropin treatment.
    Del día 1 al día 21 (ambos incluidos) de tratamiento con somatropina.
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pharmacokinetics
    Farmacocinética
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 sujeto que participa en el estudio
    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 months12
    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: 56
    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 Yes
    F.3.2Patients No
    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 state72
    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
    No procede
    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 Decision2014-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-31
    P. End of Trial
    P.End of Trial StatusOngoing
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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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