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    The EU Clinical Trials Register currently displays   44363   clinical trials with a EudraCT protocol, of which   7387   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:2011-000629-55
    Sponsor's Protocol Code Number:MRG-TEN-2011-01
    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:2011-11-03
    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 number2011-000629-55
    A.3Full title of the trial
    CLINICAL TRIAL WITH TENOFOVIR VERSUS LAMIVUDINE PLUS ADEFOVIR DIPIVOXIL IN LAMIVUDINE-RESISTANT CHRONIC HEPATITIS-B PATIENTS WITH UNDETECTABLE VIRAL LOAD
    ENSAYO CLÍNICO DE SIMPLIFICACIÓN CON TENOFOVIR EN PACIENTES CON HEPATITIS CRÓNICA B RESISTENTES A LAMIVUDINA Y CARGA VIRAL INDETECTABLE EN TRATAMIENTO CON LAMIVUDINA MÁS ADEFOVIR DIPIVOXIL (Estudio TENOSIMP-B)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL TRIAL WITH TENOFOVIR VERSUS LAMIVUDINE PLUS ADEFOVIR DIPIVOXIL IN LAMIVUDINE-RESISTANT CHRONIC HEPATITIS-B PATIENTS WITH UNDETECTABLE VIRAL LOAD
    ENSAYO CLÍNICO DE SIMPLIFICACIÓN CON TENOFOVIR EN PACIENTES CON HEPATITIS CRÓNICA B RESISTENTES A LAMIVUDINA Y CARGA VIRAL INDETECTABLE EN TRATAMIENTO CON LAMIVUDINA MÁS ADEFOVIR DIPIVOXIL (Estudio TENOSIMP-B)
    A.3.2Name or abbreviated title of the trial where available
    TENOSIMP-B
    A.4.1Sponsor's protocol code numberMRG-TEN-2011-01
    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 SponsorManuel Rodríguez García
    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 supportGilead Sciences, Inc.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmacoecomomics & Outcomes Research Iberia
    B.5.2Functional name of contact pointPORIB
    B.5.3 Address:
    B.5.3.1Street AddressCalle Segundo Mata 1, 2ª planta (oficina 16)
    B.5.3.2Town/ cityPozuelo de Alarcón
    B.5.3.3Post code28224
    B.5.3.4CountrySpain
    B.5.4Telephone number34917159147
    B.5.5Fax number34917159469
    B.5.6E-mailMA_casado@porib.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 VIREAD
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences, Inc.
    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 nameVIREAD
    D.3.2Product code J05AF07
    D.3.4Pharmaceutical form Film-coated 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 INNTENOFOVIR DISOPROXIL FUMARATO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 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 Yes
    D.2.1.1.1Trade name ZEFFIX
    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 nameZEFFIX
    D.3.2Product code J05AF07
    D.3.4Pharmaceutical form Film-coated 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 INNLAMIVUDINA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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 Yes
    D.2.1.1.1Trade name HEPSERA
    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 nameHEPSERA
    D.3.2Product code J05AF07
    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 INNADEFOVIR DIPIVOXIL
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    CHRONIC HEPATITIS B
    HEPATITIS CRÓNICA B
    E.1.1.1Medical condition in easily understood language
    CHRONIC HEPATITIS B
    HEPATITIS CRÓNICA B
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10008910
    E.1.2Term Chronic hepatitis B
    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 assess Non-inferiority of monotherapy with TENOFOVIR versus LAMIVUDINE plus ADEFOVIR DIPIVOXIL in lamovudine-resistant chronic hepatitis-B patients in undetectable viral load (DNA-HBV under lower limit of quantification) mainteinance
    ? Demostrar la no inferioridad de la monoterapia con TENOFOVIR versus la combinación de LAMOVUDINA más ADEFOVIR en pacientes con HEPATITIS CRONICA B resistentes a LAMOVUDINA, en el mantenimiento de la carga viral indetectable (ADN-VHB por debajo del LIMITE INFERIOR DE CUANTIFICACIÓN), (considerando un límite de no inferioridad del 15%).
    E.2.2Secondary objectives of the trial
    ? To estimate the number of patient (%) with undetectable viral load (DNA-VHB below the lower limit of quantification) at 12, 24 and 36 weeks of treatment
    ? To assess throughout the 48 weeks of the trial the incidence of resistance-mutations in patients with treatment failure (detection of viral replication).
    ? To estimate the number of patients (%) with AgHBe and AgHBs loss and seroreversion at 12, 24, 36 and 48 weeks.
    ? To assess the changes in AgHBs levels at 12, 24, 36 and 48 weeks
    ? To assess the treatment adherence
    ? To estimate the incremental cost between therapies
    ? To collect both clinical and laboratory adverse events
    ? Determinación del porcentaje de pacientes con carga viral indetectable (ADN-VHB por debajo del LIMITE INFERIOR DE CUANTIFICACIÓN) en las semanas 12, 24 y 36 del estudio.
    ? Evaluación de la incidencia de mutaciones de resistencia a lo largo de las 48 semanas del estudio en los pacientes que presenten rebote virológico (reaparición de la carga viral durante el periodo del estudio; es decir, ADN-VHB mayor del LIMITE INFERIOR DE CUANTIFICACIÓN).
    ? Determinación del porcentaje de pacientes que, durante las semanas 12, 24, 36 y 48 alcanzan pérdida y seroconversión del AgHBe / AgHBs.
    ? Determinación de los cambios de los niveles del AgHBs en las semanas 12, 24, 36 y 48
    ? Comparación del grado de cumplimiento terapéutico
    ? Cálculo del coste incremental
    ? Documentación de los acontecimientos adversos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Male and female patients over 18 years of age
    ? HBsAg positive at the beginning of the trial (basal visit)
    ? Patients with LAM resistant Chronic Hepatitis B
    ? Patients with LAM and ADV treatment for at least the last 6 months prior to the beginning of the trial
    ? Patients with undetectable HBV-DNA.
    ? Patients with compensated liver disease
    ? Varones o mujeres, mayores de 18 años.
    ? AgHBs positivo en suero en la visita basal
    ? Pacientes con HCB y resistencia a LAM evidenciada por test de resistencias o antecedentes de rebote virológico documentados en la historia clínica.
    ? Pacientes que se encuentren en tratamiento con LAM+ADV y que hayan recibido este tratamiento durante un mínimo de 6 meses antes del inicio del estudio.
    ? ADN-VHB indetectable al inicio del estudio (ADN-VHB por debajo del LIC)
    ? Pacientes con hepatopatía compensada.
    E.4Principal exclusion criteria
    ? Intolerance to any treatment component.
    ? Co-infection with other viruses such as HCV, HDV or HIV.
    ? Identified viral mutations associated with resistance to ADF.
    ? Presence of hepatocellular carcinoma
    ? Patients with severe or moderate renal failur
    ? Liver or kidney transplant or severe renal, lung or neurological diseases that under investigator criteria may interfere in the patient?s participation during the clinical trial.
    ? Pregnancy or breastfeeding.
    ? Treatment within the last 30 days with any experimental (non-authorised) drug.
    ?Any other disease or condition that might render the patient ineligible for the trial.
    ?Intolerancia a alguno de los componentes del régimen terapéutico.
    ?Coinfección con otros virus, tales como VHC, VHD y VIH.
    ?Mutaciones del VHB asociadas a resistencia a ADV.
    ?Presencia de carcinoma hepatocelular.
    ?Trasplante hepático o renal, o enfermedades renales, pulmonares o neurológicas graves que pudieran interferir en la participación del paciente en el estudio.
    ? Mujeres embarazadas o en período de lactancia.
    ? Tratamiento con cualquier medicamento en investigación (no aprobado) durante los últimos 30 días.
    ? Cualquier otro trastorno que, en opinión del investigador, haga al paciente inapropiado para su reclutamiento o que pueda interferir en su participación y en la conclusión del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    ? The percentage of patients with sustained virological response (undetectable HBV-DNA levels or HBV-DNA below the lower limit of quantification) after 48 weeks of treatment.
    ? Evaluación del porcentaje de pacientes que se mantienen con respuesta virológica sostenida (niveles de ADN-VHB indetectables, ADN-VHB por debajo del LIC) a las 48 semanas del estudio, mediante la técnica cuantitativa de detección de ADN-VHB que se utilice en la práctica clínica habitual en cada uno de los centros participantes
    E.5.1.1Timepoint(s) of evaluation of this end point
    ? 48 weeks
    ? 48 semanas
    E.5.2Secondary end point(s)
    ? The percentage of patients with sustained virological response (undetectable HBV-DNA levels or HBV-DNA below the lower limit of quantification) after 12, 24 and 36 weeks of treatment.
    ? Proportion of patients with treatment failure (detectable HBV-DNA levels or HBV-DNA level that exceeds the lower limit of quantification) in each treatment group.
    ? Virological response at 12, 24 and 36 weeks of treatment assessed as percentage of patients with HBeAg or HBsAg loss or seroreversion
    ? Variations in HBsAg levels after 12, 24, 36 and 48 weeks of treatment.
    ? Treatment?s adherence assessed with the Morisky-Green scale.
    ? Drug safety. Number of serious adverse events (clinical or laboratory abnormalities).
    ? Incremental cost between therapies by means of a cost-minimization analysis
    ? Evaluación del porcentaje de pacientes que se mantienen con respuesta virológica sostenida (niveles de ADN-VHB indetectables, ADN-VHB por debajo del LIC) durante las visitas de seguimiento del estudio, 12, 24 y 36 semanas, mediante la técnica cuantitativa de detección de ADN-VHB que se utilice en la práctica clínica habitual en cada uno de los centros participantes:
    ? Comparación de la proporción de pacientes con rebote virológico (reaparición de la carga viral durante el periodo del estudio; es decir, ADN-VHB mayor del LIC) en cada brazo que desarrolla resistencias a ADV o a TDF durante las 48 semanas de tratamiento.
    ? Comparación de la respuesta virológica en las semanas 12, 24, 36 y 48:
    - Pérdida del AgHBe y seroconversión (Anti-HBe) en los pacientes AgHBe positivo al inicio del estudio.
    - Pérdida del AgHBs y seroconversión (Anti-HBs).
    ? Determinación de los cambios (disminución) de los niveles del AgHBs en las semanas 12, 24, 36 y 48.
    ? Comparación del grado de cumplimiento terapéutico entre ambos grupos de tratamiento o Mediante la escala Morisky-Green y mediante el registro de la toma de medicación
    ? Evaluación de la seguridad. Determinación de los acontecimientos adversos graves (clínicos y de laboratorio) y su relación con los fármacos administrados en cada visita.
    ? Cálculo del coste incremental de los pacientes tratados con TDF frente a los tratados con LAM+ADV mediante un análisis de minimización de costes
    ? after 48 weeks of treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ? after 12, 24 and 36 weeks of treatment.
    ? after 12, 24, 36 and 48 weeks of treatment.
    ? after 12, 24 and 36 weeks of treatment.
    ? after 12, 24, 36 and 48 weeks of treatment.
    ? after 48 weeks of treatment.
    ? after 48 weeks of treatment.
    ? tras 12, 24 y 36 semanas de tratamiento
    ? tras 12, 24, 36 y 48 semanas de tratamiento
    ? tras 12, 24 y 36 semanas de tratamiento
    ? tras 12, 24, 36 y 48 semanas de tratamiento
    ? tras 48 semanas de tratamiento
    ? tras 48 semanas de tratamiento
    ? tras 48 semanas de tratamiento
    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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned16
    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
    ?The end of the trial will coincide with the day of the last visit for the last recruited patinet
    ? La fecha de finalización del ensayo coincidirá con la fecha de la última visita para el último paciente reclutado.
    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 months5
    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 months5
    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: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    expected normal treatment of that condition
    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 Decision2011-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
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