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    Summary
    EudraCT Number:2008-002039-34
    Sponsor's Protocol Code Number:CABF656B2202
    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:2008-10-03
    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 number2008-002039-34
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, abierto, de búsqueda de dosis y controlado con tratamiento activo, para evaluar la seguridad y eficacia de albinterferón alfa-2b administrado cada 4 semanas junto con ribavirina, en pacientes sin tratamiento previo con interferón alfa que presentan hepatitis C crónica genotipo 2/3
    A.4.1Sponsor's protocol code numberCABF656B2202
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Farmaceutica 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    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 Pegasys
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNPEGINTERFERON ALFA 2A
    D.3.9.3Other descriptive namePEGINTERFERON ALFA 2A
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typepeginterferon alfa-2a
    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 No
    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 namealbinterferon alfa-2b
    D.3.2Product code ABF656
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNalbumin interferon alfa-2b
    D.3.9.1CAS number 472960-22-8
    D.3.9.2Current sponsor codeABF656
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.4
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeproteina de fusión recombinante albumina interferon alfa-2b
    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 Ribasphere
    D.2.1.1.2Name of the Marketing Authorisation holderThree Rivers Pharmaceuticals, LLc
    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 nameRibasphere
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNribavirin
    D.3.9.1CAS number 36791-04-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Hepatitis C crónica
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10008912
    E.1.2Term Chronic hepatitis C
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la seguridad y tolerabilidad de hasta cuatro dosis de alb-IFN Q4w (900 µg, 1200 µg, 1500 µg y posiblemente 1800 µg) junto con RBV diaria en pacientes sin tratamiento previo con IFN? que presentan HCC genotipo 2/3.
    E.2.2Secondary objectives of the trial
    Caracterizar la eficacia de hasta 4 dosis de alb-IFN Q4w (900 µg, 1200 µg,1500 µg y 1800) junto RBV diaria determinada por:
    ?Respuesta Virológica Sostenida (RVS), definida como ARN-HCV indetectable (es decir, ARN-VHC < límite de detección [LOD]; 15 UI/mL) a las 24 semanas post-tratamiento
    ?Respuesta Virológica por debajo del LOQ (43 IU/mL) en la Semana de tratamiento 12 (TW12).
    ?Respuesta Virológica Rápida en la Semana de tratamiento 4 (RVR4), definida como ARN-VHC < límite de cuantificación (LOQ [43 UI/mL])
    ?Respuesta Virológica Precoz en la Semana de tratamiento 12 (EVR12), definida como una reducción ? 2 log10 ó ARN-VHC < LOQ (43 UI/mL)
    ?Respuesta al final del Tratamiento (ETR), definida como ARN-VHC indetectable (< LOD [15 UI/mL]) en la Semana 24 o en la visita más próxima a la fecha de la última dosis de interferón o RBV dentro de una ventana de ±27 días
    ?Cambio con respecto a la basal en el ARN-VHC de log10 en las Semanas 4 y 12
    ?Tiempo hasta ARN-VHC < LOD (15 UI/mL)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.De 18 años de edad o mayores
    2.Diagnóstico clínico de hepatitis C crónica, incluido ARN-VHC detectable en el momento de la selección
    3.Estar infectado con el VHC genotipo 2 ó 3. No se incluirá en el estudio a los sujetos infectados con genotipos mixtos del VHC (p. ej., genotipo 1/2, 1/3, 2/3 etc.) en la selección. Se podrá incluir en el estudio a los sujetos con genotipos mixtos 2a/2b ó 3a/3b.
    4.Sin tratamiento previo con terapia basada en IFN?
    5.Capacidad para otorgar el consentimiento informado por escrito de acuerdo con las pautas del hospital y de las autoridades regulatorias; dispuestos y capaces de cumplir con los procedimientos del protocolo del estudio
    E.4Principal exclusion criteria
    1.Mujeres en edad fértil (WOCBP), A NO SER QUE (1) cumplan la siguiente definición de postmenopausia: 12 meses de amenorrea natural (espontánea) con un perfil clínico apropiado o (2) 6 semanas después de una intervención de ovariectomía bilateral con o sin histerectomía o (3) están de acuerdo en utilizar al menos dos métodos anticonceptivos fiables durante el tratamiento y durante el período de seguimiento post-tratamiento de 7 meses.
    2.Los hombres fértiles podrán ser incluidos en este estudio si el paciente está de acuerdo en utilizar preservativos junto con espermicida y su pareja femenina está de acuerdo en utilizar uno o más de los métodos anticonceptivos aceptables arriba indicados, desde la fecha de la selección hasta 7 meses después de su última dosis de RBV
    3.Mujeres embarazadas o en período de lactancia.Hombres cuyas parejas femeninas estén embarazadas o considerando la posibilidad de quedarse embarazadas
    4.Antecedentes o indicios actuales de hepatopatía descompensada (ascitis, hemorragia por varices encefalopatía hepática, u otros signos de hipertensión portal progresiva o insuficiencia hepática progresiva [protrombina INR > 1,4; seroalbúmina < 3,5 g/dl]))
    5.Otras formas de hepatopatía (p. ej., alcohólica, autoinmunitaria, biliar, o de Wilson): No obstante, los síndromes de Gilbert o de Dubin-Johnson no excluirán a los pacientes
    6.Coinfección con el virus de la hepatitis B (VHB) o con el virus de inmunodeficiencia humana (VIH)
    7.Antecedentes de enfermedad psiquiátrica moderada, severa o incontrolada (p. ej., depresión [incluidos antecedentes de hospitalización o intento previo de suicidio], enfermedad bipolar, esquizofrenia, o trastorno de la personalidad). Se podrá considerar a los pacientes con antecedentes de depresión leve y estable, siempre y cuando exista una valoración que se haya realizado antes del tratamiento (que incluya una puntuación del estado afectivo del paciente en la subescala de depresión [HADS-D] de la Escala de Ansiedad y Depresión Hospitalaria [HADS] de ? 8) que corrobore que el paciente está clínicamente estable. Los pacientes con una puntuación de HADS-D de > 8 precisarán una evaluación clínica adicional de la depresión antes de la inclusión en el estudio. Para estos pacientes, el investigador deberá formular y documentar un plan de tratamiento de la depresión previo a la aleatorización, y en cada visita deberá revisar el estado afectivo del paciente de acuerdo con el plan. Los pacientes con una puntuación en la subescala de ansiedad de HADS (HADS-A) de > 8 podrán ser reclutados a juicio del investigador.
    8.Antecedentes de trastornos convulsivos
    9.Antecedentes o evidencia clínica de cardiopatía crónica; ECG con anormalidad clínicamente significativa. Síndrome de QT Largo o QTc >450 mseg en hombres y > 470 mseg en mujeres en la visita de selección o basal.
    10.Indicios clínicos de enfermedad pulmonar intersticial preexistente
    11.Indicios clínicos de enfermedad pulmonar grave
    12.Hallazgos clínicamente significativos en la oftalmoscopia o en el examen de retina observados en la selección según el criterio clínico del investigador o por el oftalmólogo/optometrista en el caso de pacientes diabéticos
    13.Antecedentes de enfermedad mediada inmunológicamente
    14.Trasplante de órgano, que no sea trasplante de córnea o de cabello
    15.Antecedentes de hemoglobinopatía clínicamente significativa
    16.Diagnóstico de enfermedad maligna de cualquier sistema orgánico, tratado o no tratado, durante los últimos 5 años
    17.Antecedentes de intolerancia a la galactosa, deficiencia de Lapp lactasa o mala absorción de glucosa-galactosa
    18.Antecedentes de hipersensibilidad a cualquiera de las medicaciones del estudio o a fármacos con estructuras químicas similares
    19.Adicción a fármacos o alcohol durante los últimos 6 meses y/o resultado positivo en el análisis de consumo de drogas (opiáceos, barbitúricos, anfetaminas, o cocaína).
    20.Antecedentes de cualquier otra enfermedad por la que, en opinión del investigador, el paciente no sería apto para participar en el estudio.
    21.Se les administraron corticoesteroides por vía sistémica dentro de los 14 días anteriores a la visita Basal
    22.Se les administraron antibióticos, antifúngicos o antivirales concomitantes por vía sistémica para el tratamiento de infección activa dentro de los 14 días anteriores a la visita Basal.
    23.Se les administraron terapias a base de hierbas medicinales o un fármaco en investigación dentro de los 35 días anteriores a la visita Basal
    24.Presentan un resultado de laboratorio anormal clínicamente significativo en la selección.
    E.5 End points
    E.5.1Primary end point(s)
    El objetivo principal es evaluar la seguridad y eficacia de una pauta posológica de 4 semanas (Q4w) con albinterferón alfa-2b (alb-IFN) junto con ribavirina (RBV) diaria en pacientes sin tratamiento previo con IFN? que presentan hepatitis C crónica (HCC) genotipo 2/3.
    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 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 Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    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 Yes
    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.8.3 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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
    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 months1
    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 months1
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 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.1.3Elderly (>=65 years) Yes
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 296
    F.4.2.2In the whole clinical trial 525
    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 Decision2008-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
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