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    Summary
    EudraCT Number:2011-001077-13
    Sponsor's Protocol Code Number:CICL670A2417
    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:2011-08-26
    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 number2011-001077-13
    A.3Full title of the trial
    Estudio clínico multicéntrico, aleatorizado, comparativo, de distintos regímenes de administración de deferasirox en la tolerabilidad gastrointestinal (GI), en pacientes con síndrome mielodisplásico (SMD) de riesgo bajo o intermedio (int-1) con sobrecarga de hierro transfusional
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Estudio clínico multicéntrico, aleatorizado, comparativo, de distintos regímenes de administración de deferasirox en la tolerabilidad gastrointestinal (GI), en pacientes con síndrome mielodisplásico (SMD) de riesgo bajo o intermedio (int-1) con sobrecarga de hierro transfusional
    A.4.1Sponsor's protocol code numberCICL670A2417
    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 SponsorNovartis Farmacéutica 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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica S.A.
    B.5.2Functional name of contact pointJavier Malpesa
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes,
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number0034 93 306 44 64
    B.5.5Fax number0034 93 306 46 15
    B.5.6E-maileecc.novartis@novartis.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 EXJADE 125 mg comprimidos dispersables
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS EUROPHARM LTD.
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/02/092
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Dispersible tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEFERASIROX
    D.3.9.3Other descriptive nameDEFERASIROX
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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.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 Yes
    D.2.1.1.1Trade name EXJADE 500 mg comprimidos dispersables
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS EUROPHARM LTD.
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/02/092
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Dispersible tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEFERASIROX
    D.3.9.3Other descriptive nameDEFERASIROX
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.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 Yes
    D.2.1.1.1Trade name EXJADE 250 mg comprimidos dispersables no se ha podido seleccionar España como estado en que se encuentra autorizado, ya que esta dosis no se halla comercializada en España, aunque sí autorizada, por procedimiento centralizado (para toda la UE)
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limted
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/02/092
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Dispersible tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEFERASIROX
    D.3.9.3Other descriptive nameDEFERASIROX
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    Sobrecarga de hierro de riesgo bajo o intermedio (int-1) en pacientes con síndrome mielodisplásico (SMD) con ferritina > 1000 mcg/L en la selección o antecedentes de transfusión de por lo menos 20 unidades de hematíes
    E.1.1.1Medical condition in easily understood language
    Sobrecarga de hierro
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level HLT
    E.1.2Classification code 10022979
    E.1.2Term Iron excess
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparar la frecuencia de acontecimientos adversos GI de aparición reciente, en dos regímenes de administración distintos de deferasirox, después de 3 meses de tratamiento
    E.2.2Secondary objectives of the trial
    Comparar la frecuencia de acontecimientos adversos GI de aparición reciente, en los dos regímenes de administración de deferasirox, a los 6 meses.
    Comparar la frecuencia de acontecimientos adversos GI específicos notificados comúnmente en los dos regímenes de administración de deferasirox.
    Comparar la severidad de los síntomas GI totales en los dos regímenes de administración de deferasirox.
    Comparar la severidad de los síntomas GI específicos, notificados comúnmente, en los dos regímenes de administración de deferasirox.
    Evaluar la seguridad y la tolerabilidad de los dos regímenes de administración de deferasirox, comparando la frecuencia y la severidad de los acontecimientos adversos no GI.
    Comparar el periodo de tiempo desde la visita basal hasta la primera aparición de acontecimientos adversos GI entre los dos regímenes de administración.
    Evaluar la diferencia entre los dos grupos de tratamiento en la severidad de los síntomas GI, hábitos intestinales y nivel de satisfacción.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Consentimiento informado por escrito obtenido antes de realizar cualquier procedimiento de selección
    Pacientes hombres o mujeres 18 años de edad
    Pacientes con SMD de riesgo bajo o intermedio (int-1), determinado con la puntuación del IPSS o RA, RARS con los criterios de la OMS. El IPSS deberá estar confirmado con un examen de la médula ósea dentro de los 6 meses antes del inicio del estudio y deberá ser hematológicamente estable
    Ferritina > 1000 mcg/L en la selección o antecedentes de transfusión de por lo menos 20 unidades de hematíes.
    Pacientes que no hayan sido tratados con Deferasirox
    Las mujeres premenopáusicas sexualmente activas deberá utilizar anticonceptivos de barrera doble, anticonceptivos orales más contraceptivos de barrera o deberán haber sido sometidas a histerectomía total documentada y/o a ooforectomía, ligadura de trompas.
    E.4Principal exclusion criteria
    Aclaramiento de creatinina < 40 mL/min, excepto en los casos donde la pauta ya esté establecida en la etiqueta local de deferasirox, que indique que el aclaramiento de creatinina debería ser < 60 mL/min
    Creatinina sérica >1. 2x LSN en la selección
    Proteinuria significativa indicada con un cociente de creatinina/proteína urinaria > 0.5 mg/mg en una muestra de orina no recogida de la primera micción matutina en la visita 1 o en la visita 2 (o alternativamente en dos de tres muestras obtenidas para la selección)
    ECOG > 2
    Fracción de eyección ventricular izquierda < 50%, con ecocardiografía
    Enfermedades sistémicas que podrían impedir el tratamiento del estudio (por ejemplo, hipertensión mal controlada, cardiovasculares, renales, hepáticas, metabólicas, etc.)
    Evidencia clínica o de laboratorio de hepatitis B o de hepatitis C activa (HBsAg en ausencia de HBsAb O VHC Ac positivo con ARN VHC positivo)
    Antecedentes de resultados positivos en el test del VIH (Elisa o Westernblot)
    Tratamiento con fármacos en investigación sistémicos durante 4 semanas o fármacos en investigación tópicos durante los 7 días previos al inicio del estudio.
    Recuento de plaquetas < 25x 109/L, excepto en los casos donde la pauta ya esté establecida en la etiqueta local de deferasirox, e indique que el recuento de plaquetas debería ser < 50x 109/L
    ALT o AST > 2.5 x LSN en la visita de selección
    Bilirrubina total > LSN en la visita de selección
    Diagnóstico de cirrosis hepática
    Pacientes que participen en otro ensayo clínico que no sea un estudio de registro observacional
    Pacientes con antecedentes de otras enfermedades malignas durante los últimos cinco años, con la excepción de carcinoma cutáneo de células basales o carcinoma cervical in situ.
    Pacientes con hipersensibilidad conocida a deferasirox o a alguno de sus componentes
    Antecedentes de incumplimiento con regímenes médicos o pacientes que se consideren potencialmente no fiables y/o no cooperativos
    Presencia de una condición médica o quirúrgica que pueda alterar significativamente la absorción, distribución, metabolismo o excreción de la medicación del estudio
    Antecedentes de abuso de alcohol o fármacos durante los 12 meses previos a la inclusión.
    Antecedentes de cirugía del tracto gastrointestinal superior como gastrectomía, gastroenterostomía o resección intestinal
    Antecedentes o enfermedad GI actual
    Pacientes con sensibilidad GI, por ejemplo, intolerancia a la lactosa
    Los pacientes que se averigüe que no son elegibles después de los procedimientos de selección, deberán tener esto documentado en el registro de selección. No es necesario que estos pacientes completen las evaluaciones de final del estudio
    Pacientes embarazadas o que pretendan quedarse embarazadas o en periodo de lactancia
    Pacientes físicamente fértiles, definidas como todas las mujeres fisiológicamente capaces de quedarse embarazadas, incluyendo las mujeres cuya trayectoria, estilo de vida u orientación sexual excluya el coito con un varón y mujeres cuyas parejas hayan sido esterilizados con vasectomía u otros métodos, A NO SER QUE estén utilizando dos métodos anticonceptivos de barrera doble. Los dos métodos pueden ser un método de barrera doble o un método de barrera más un método hormonal.
    Los métodos anticonceptivos de barrera adecuados incluyen: diafragma, preservativo (por la pareja), dispositivo intrauterino (de cobre u hormonal), esponja o espermicida. Los anticonceptivos hormonales incluyen cualquier anticonceptivo comercializado que incluya un agente estrogénico y/o progestacional.
    Los métodos anticonceptivos fiables deberían mantenerse durante todo el estudio y durante 28 días después de la retirada de la medicación del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal es la diferencia en la frecuencia de acontecimientos adversos GI de aparición reciente, en los dos regímenes de administración de deferasirox, a los 3 meses.
    E.5.1.1Timepoint(s) of evaluation of this end point
    La variable principal es la diferencia en la frecuencia de acontecimientos adversos GI de aparición reciente, en los dos regímenes de administración de deferasirox, a los 3 meses.
    E.5.2Secondary end point(s)
    Comparar la frecuencia de acontecimientos adversos GI de aparición reciente, en los dos regímenes de administración de deferasirox, a los 6 meses
    Comparar la frecuencia de acontecimientos adversos GI específicos notificados comúnmente en los dos regímenes de administración de deferasirox.
    Comparar la severidad de los síntomas GI totales en los dos regímenes de administración de deferasirox
    Comparar la severidad de los síntomas GI específicos, notificados comúnmente, en los dos regímenes de administración de deferasirox
    Evaluar la seguridad y la tolerabilidad de los dos regímenes de administración de deferasirox, comparando la frecuencia y la severidad de los acontecimientos adversos no GI
    E.5.2.1Timepoint(s) of evaluation of this end point
    Comparar la frecuencia de acontecimientos adversos GI de aparición reciente, en los dos regímenes de administración de deferasirox, a los 6 meses
    Comparar la frecuencia de acontecimientos adversos GI específicos notificados comúnmente en los dos regímenes de administración de deferasirox.
    Comparar la severidad de los síntomas GI totales en los dos regímenes de administración de deferasirox
    Comparar la severidad de los síntomas GI específicos, notificados comúnmente, en los dos regímenes de administración de deferasirox
    Evaluar la seguridad y la tolerabilidad de los dos regímenes de administración de deferasirox, comparando la frecuencia y la severidad de los acontecimientos adversos no GI
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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
    France
    Germany
    Japan
    Russian Federation
    Spain
    United States
    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
    Último paciente última visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 172
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 172
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 82
    F.4.2.2In the whole clinical trial 172
    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)
    No diferente del tratamiento normal esperado para esta condición.
    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 Decision2011-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-09-14
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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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