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    Summary
    EudraCT Number:2011-001449-34
    Sponsor's Protocol Code Number:CMV-INMUNOGUIA
    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:2011-06-14
    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 number2011-001449-34
    A.3Full title of the trial
    Phase II study, multicenter, prospective, open label, preemptive treatment of cytomegalovirus (CMV) infection driven by virologic monitoring and quantification of T CD8pp65/IE-1-IFNgamma+ lymphocytes in allogeneic hematopoietic transplantation
    Estudio en fase II, multicéntrico, prospectivo, abierto, de tratamiento anticipado de la infección por citomegalovirus (CMV) guiado por la monitorización virológica y la cuantificación de linfocitos T CD8pp65/IE-1-IFNgamma+ en el transplante alogénico de progenitores hematopoyéticos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study for the treatment of cytomegalovirus infection, in transplanted patients
    Estudio para el tratamiento de la infeccion por citomegalovirus, en pacientes trasplantados.
    A.4.1Sponsor's protocol code numberCMV-INMUNOGUIA
    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 SponsorFUNDACION INVESTIGACION HOSPITAL CLINICO DE VALENCIA-INSTITUTO DE INVESTIGACION SANITARIA INCLIVA
    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 supportMinisterio de Sanidad y Politica Social
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACION INVESTIGACION HOSPITAL CLINICO DE VALENCIA-INSTITUTO DE INVESTIGACION SANITARIA INCLIVA
    B.5.2Functional name of contact pointUNIDAD ENSAYOS CLINICOS
    B.5.3 Address:
    B.5.3.1Street AddressAVENIDA BLASCO IBAÑEZ, 17
    B.5.3.2Town/ cityVALENCIA
    B.5.3.3Post code46010
    B.5.3.4CountrySpain
    B.5.4Telephone number34963862894
    B.5.5Fax number34963987860
    B.5.6E-mailfundacioninvestigacion_hcv@gva.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 CYMEVENE
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE FARMA, S.A.
    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 nameGANCICLOVIR
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGANCICLOVIR SODICO
    D.3.9.3Other descriptive nameGANCICLOVIR SODIUM
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number54.6
    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 FOSCAVIR
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca Farmacéutica Spain, S.A.
    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 nameFOSCARNET
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFOSCARNET SODICO
    D.3.9.1CAS number 63585-09-1
    D.3.9.3Other descriptive nameFOSCARNET SODIUM
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number24
    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 VALCYTE
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE FARMA, S.A.
    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 nameVALGANCICLOVIR
    D.3.4Pharmaceutical form 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 INNVALGANCICLOVIR
    D.3.9.3Other descriptive nameVALGANCICLOVIR
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number450
    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
    Cytomegalovirus infection in patients treated with hematopoietic allogenic transplant
    INFECCION POR CITOMEGALOVIRUS EN PACIENTES TRATADOS CON TRASPLANTE HEMATOPOYETICO ALOGENICO
    E.1.1.1Medical condition in easily understood language
    Cytomegalovirus infection in transplanted patients
    Infeccion por citomegalovirus en pacientes trasplantados
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level HLT
    E.1.2Classification code 10011827
    E.1.2Term Cytomegaloviral infections
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether a strategy of early treatment of CMV infection post hematopoietic allogeneic transplant, guided by virological monitoring and quantification of T CD8pp65/IE-1-IFNgamma+ lymphocytes is at least the same or more effective than the standard strategy (historical control group).
    Determinar si una estrategia de tratamiento anticipado de la infección CMV post-TPH alogénico guiada por la monitorización virológica y la cuantificación de linfocitos T CD8pp65/IE-1-IFNgamma+ es al menos igual o más eficaz que la estrategia estándar (grupo control histórico).
    E.2.2Secondary objectives of the trial
    Compare two strategies for toxicity (especially myelo and nephrotoxicity) and duration of antiviral treatment.

    Secondary endpoints of safety assessment: percentage of patients who:
    - Having achieved hematologic recovery, develop neutropenia of <1.0 x109/L and <0.5 x109/L, during the first 100 days of TPH.
    - Develop nephrotoxicity in the first 100 days of TPH, defined as doubling of baseline creatinine figure, or rise by at least 1 mg/dl.
    - Develop CMV disease during treatment or within following 2 months.
    - Develop antigenemia/PCR positive in blood in the 2 months following treatment completion.
    - Frequency and type of infections during treatment and 2 months follow up.

    Secondary endpoint evaluation of efficacy:
    - Total days of antiviral treatment
    Comparar ambas estrategias en cuanto a toxicidad (especialmente mielo y nefrotoxicidad) y duración de tratamiento antiviral.

    Variables secundarias de evaluación de la seguridad: porcentaje de pacientes que:
    -Tras haber alcanzado la recuperación hematológica, desarrollen neutropenia de <1.0 x109/L y < 0,5 x109/L, durante los primeros 100 días de TPH.
    -Desarrollan nefrotoxicidad en los primeros 100 días de TPH, definida como el aumento al doble de la cifra basal de creatinina, o cuando se eleve en al menos 1 mg/dl.
    -Desarrollen enfermedad por CMV durante el tratamiento o en los 2 meses siguientes.
    -Desarrollen de antigenemia/PCR positiva en sangre en los 2 meses siguientes a finalizar el tratamiento.
    -Frecuencia y tipo de infecciones durante el tratamiento y los 2 meses de seguimiento.

    Variable secundaria de evaluación de eficacia:
    -Días totales de tratamiento antiviral
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients older than 18.
    -Patients undergoing any form of allogeneic hematopoietic progenitors transplant.
    -Positive CMV serology in patient and/or donor.
    -Prospective virologic and immune monitoring and systematic posttransplant .
    -First episode of CMV detection in blood by antigemia or PCR before day +100 after transplantation. The level of pp65 antigenemia or PCR-CMV by quantitative PCR used in each participating center is detailed in Annexe II.
    -The first anti-CMV treatment should be made as soon as possible to the positive antigenemia or PCR, with a maximum of 72h after obtaining the positive test to determine the start of treatment.
    -Signing the informed consent to participate in the study.
    -Negative pregnancy test in patients of childbearing age.
    -Pacientes con edad superior a 18 años.
    -Pacientes sometidos a cualquier modalidad de trasplante alogénico de progenitores hematopoyéticos.
    -Serología CMV positiva en paciente y/o donante
    -Seguimiento virológico e inmunológico prospectivo y de sistemático postrasplante
    -Primer episodio de detección de CMV en sangre mediante antigenemia o por PCR antes del día +100 postrasplante. El nivel de antigenemia pp65 o de PCR-CMV mediante PCR cuantitativa utilizado en cada centro participante se detalla en el Anexo II.
    -El inicio del tratamiento anti-CMV deberá realizarse lo antes posible ante la positividad de la antigenemia o PCR, con un máximo de 72h desde la obtención de la prueba positiva que determine el inicio de dicho tratamiento.
    -Firmar el consentimiento informado para participar en el estudio.
    -Test de embarazo negativo, en pacientes en edad férti
    E.4Principal exclusion criteria
    -Patients receiving autologous or syngeneic transplant.
    -Patients <50 kg in weight.
    -Patients with a history of allergy or hypersensitivity to valganciclovir, ganciclovir or acyclovir. Due to the similarity in chemical structure of valganciclovir, aciclovir and valaciclovir, is likely to occur cross-hypersensitivity reaction between these drugs so Valganciclovir is contraindicated in patients with hypersensitivity to aciclovir and valaciclovir.
    -Disease-tested for this virus is detected when the infection or who are in suspicious box evaluation of CMV disease.
    -Have submitted 1 episode of CMV infection before the current episode.
    -Submit severe liver disease defined by a bilirubin ? 10 mg/dl.
    -Have received foscarnet, ganciclovir, cidofovir or other antiviral agent with activity against CMV clear within 30 days prior to the current episode. The use of acyclovir is allowed, as immunoglobulins.
    -Less than 500 neutrophils / mm3, despite treatment with G-CSF, at the time of starting treatment. Patients with> 500 PMN / mm3 but <1000 neutrophils / mm3 should start treatment with G-CSF for neutrophil count is always> 1000 / mm3.
    -Platelets <25,000 / mm3 despite transfusion.
    -Creatinine clearance <10 ml / min or patients on dialysis. These patients should not receive valganciclovir.
    -Patients who are pregnant or breastfeeding, if they are women of childbearing age should have a negative pregnancy test (urine or serum) and use effective contraception
    -Pacientes receptores de trasplante autólogo o singénico.
    -Pacientes de <50 kg de peso.
    -Pacientes con antecedentes de alergia o hipersensibilidad conocida al valganciclovir, ganciclovir o aciclovir. Debido a la semejanza en la estructura química del valganciclovir, aciclovir y valaciclovir, es posible que ocurra una reacción de hipersensibilidad cruzada entre estos medicamentos por lo que el valganciclovir está contraindicado en pacientes con hipersensibilidad a aciclovir y valaciclovir.
    -Enfermedad probada por este virus en el momento de detectarse la infección o que estén en evaluación por cuadro sospechoso de enfermedad por CMV.
    -Haber presentado 1 episodio de infección por CMV anterior al episodio actual.
    -Presentar hepatopatía severa definida por una bilirrubina 10?mg/dl.
    -Haber recibido foscarnet, ganciclovir, cidofovir u otro agente antiviral con clara actividad frente al CMV en los 30 días previos al episodio actual. El empleo de aciclovir se permite, al igual que las inmunoglobulinas.
    -Neutrófilos inferiores a 500 /mm3; a pesar de tratamiento con G-CSF, en el momento de iniciar el tratamiento. Los pacientes con >500 PMN/mm3 pero <1000 PMN /mm3 deberán iniciar tratamiento con G-CSF para que la cifra de neutrófilos sea siempre >1000 /mm3.
    -Plaquetas < 25,000 / mm3 pese a transfusión.
    -Aclaramiento de creatinina <10 ml/min o pacientes en diálisis. Estos pacientes no deberán recibir valganciclovir.
    -Pacientes embarazadas o en periodo de lactancia, si se trata de mujeres en edad fértil deben disponer de una prueba de embarazo negativa (orina o suero) y utilizar métodos anticonceptivos efi
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint of efficacy: percentage of patients with negativity of CMV in blood at the end of treatment (assessment at 7, 14, 21 and 28 days) and no relapse within 2 months after completion of treatment, measured from the initiation of therapy and after completion of treatment administered. This figure is compared with that in the historical control group treated as standard in the institutions participating in this project.
    Variable principal de evaluación de eficacia:
    -Porcentaje de pacientes con negativización del CMV en sangre al finalizar el tratamiento (valoración a los 7, 14, 21 y 28 días) y no recidivan en los 2 meses siguientes a la finalización del tratamiento, medidos desde el inicio del tratamiento y después de finalizar el tratamiento administrado. Esta cifra se comparará con la obtenida en el grupo control histórico tratados de forma estándar en los centros participantes en este proyecto.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Percentage of patients with negativity of CMV in blood at the end of treatment (assessment at 7, 14, 21 and 28 days) and no relapse within 2 months after completion of treatment, measured from the initiation of therapy and after completion of treatment administered.
    Porcentaje de pacientes con negativización del CMV en sangre al finalizar el tratamiento (valoración a los 7, 14, 21 y 28 días) y no recidivan en los 2 meses siguientes a la finalización del tratamiento, medidos desde el inicio del tratamiento y después de finalizar el tratamiento administrado.
    E.5.2Secondary end point(s)
    Compare two strategies for toxicity (especially myelo and nephrotoxicity) and duration of antiviral treatment.

    Secondary endpoints of safety assessment: percentage of patients who:
    -Having achieved hematologic recovery, develop neutropenia of <1.0 x109 / L and <0.5 x109 / L, during the first 100 days of TPH.
    -Develop nephrotoxicity in the first 100 days of TPH, defined as doubling of baseline creatinine figure, or rise by at least 1 mg/dl.
    -Develop CMV disease during treatment or within 2 following months.
    -Develop antigenemia / PCR positive in blood in the 2 months following treatment completion.
    -Frequency and type of infections during treatment and 2 months follow up.

    Secondary endpoint evaluation of efficacy:
    -Total days of antiviral treatment.
    Comparar ambas estrategias en cuanto a toxicidad (especialmente mielo y nefrotoxicidad) y duración de tratamiento antiviral.

    Variables secundarias de evaluación de la seguridad: porcentaje de pacientes que:
    -Tras haber alcanzado la recuperación hematológica, desarrollen neutropenia de <1.0 x109/L y < 0,5 x109/L, durante los primeros 100 días de TPH.
    -Desarrollan nefrotoxicidad en los primeros 100 días de TPH, definida como el aumento al doble de la cifra basal de creatinina, o cuando se eleve en al menos 1 mg/dl.
    -Desarrollen enfermedad por CMV durante el tratamiento o en los 2 meses siguientes.
    -Desarrollen de antigenemia/PCR positiva en sangre en los 2 meses siguientes a finalizar el tratamiento.
    -Frecuencia y tipo de infecciones durante el tratamiento y los 2 meses de seguimiento.

    Variable secundaria de evaluación de eficacia:
    -Días totales de tratamiento antiviral.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints of safety assessment: percentage of patients who:
    -Having achieved hematologic recovery, develop neutropenia of <1.0 x109 / L and <0.5 x109 / L, during the first 100 days of TPH.
    -Develop nephrotoxicity in the first 100 days of TPH, defined as doubling of baseline creatinine figure, or rise by at least 1 mg/dl.
    -Develop CMV disease during treatment or within 2 following months.
    -Develop antigenemia / PCR positive in blood in the 2 months following treatment completion.
    -Frequency and type of infections during treatment and 2 months follow up.

    Secondary endpoint evaluation of efficacy:
    -Total days of antiviral treatment.
    Variables secundarias de evaluación de la seguridad: porcentaje de pacientes que:
    -Tras haber alcanzado la recuperación hematológica, desarrollen neutropenia de <1.0 x109/L y < 0,5 x109/L, durante los primeros 100 días de TPH.
    -Desarrollan nefrotoxicidad en los primeros 100 días de TPH, definida como el aumento al doble de la cifra basal de creatinina, o cuando se eleve en al menos 1 mg/dl.
    -Desarrollen enfermedad por CMV durante el tratamiento o en los 2 meses siguientes.
    -Desarrollen de antigenemia/PCR positiva en sangre en los 2 meses siguientes a finalizar el tratamiento.
    -Frecuencia y tipo de infecciones durante el tratamiento y los 2 meses de seguimiento.

    Variable secundaria de evaluación de eficacia:
    -Días totales de tratamiento antiviral.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    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
    BRAZO UNICO
    ONE ARM
    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 HISTORICO EN MISMOS CENTROS
    HISTORICAL CONTROL IN SITES
    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 concerned7
    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
    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 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: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 64
    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)
    REGULAR MONITORING IN PATIENTS TREATED WITH ALLOGENIC HEMATOPOIETIC TRANSPLANTATION
    SEGUIMIENTO HABITUAL EN PACIENTES TRATADOS CON TRANSPLANTE HEMATOPOYETICO ALOGENICO
    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 Decision2011-08-19
    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
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