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    Summary
    EudraCT Number:2009-009438-34
    Sponsor's Protocol Code Number:HEPAVIR_IFN_2009
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-03-31
    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 number2009-009438-34
    A.3Full title of the trial
    Eficacia de dosis altas de interferón pegilado alfa-2a y ribavirina en el retratamiento de pacientes con cirrosis hepática por virus C (genotipos 1 o 4), coinfectados por el VIH, no respondedores a un tratamiento previo con dosis estándares de interferón pegilado y ribavirina.
    A.4.1Sponsor's protocol code numberHEPAVIR_IFN_2009
    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 SponsorLuis Fernando López Cortés
    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 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 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 PEGASYS, 180 microgramos, solución inyectable en jeringa precargada
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    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.3.4Pharmaceutical form Suspension 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 microgram(s)
    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 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 COPEGUS 400 mg comprimidos recubiertos con pelicula
    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.3.4Pharmaceutical form Tablet
    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 INNRIBAVIRINA
    D.3.9.1CAS number 36791-04-5
    D.3.9.3Other descriptive nameRIBAVIRIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Yes
    D.3.11.13.1Other medicinal product typeOf chemical origin
    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
    Pacientes con cirrosis hepática compensada por virus C (genotipos 1 o 4) coinfectados por el VIH
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia, medida como respuesta viral sostenida, de dosis altas de interferón pegilado alfa-2a (360 µg/semana) junto con ribavirina (1600 mg/día) en el retratamiento de pacientes con cirrosis hepática por virus C (genotipos 1 o 4), coinfectados por el VIH, sin respuesta virológica (*) previa a un tratamiento con dosis estándares de ambos fármacos.
    E.2.2Secondary objectives of the trial
    ?Analizar el beneficio en el grado de fibrosis hepática, medido mediante fibroscan, al finalizar el tratamiento respecto al basal.
    ?Evaluar la incidencia y severidad de los efectos adversos de este régimen posológico.
    ?Analizar la relación entre las concentraciones plasmáticas de IFN-? y ribavirina con la respuesta viral y con la incidencia y gravedad de efectos adversos.
    ?Asimismo, se evaluará la eficacia virológica de este régimen posológico en diferentes intervalos durante el tratamiento: respuesta viral precoz (4ª semana), respuesta viral temprana (12ª semana de tratamiento y al finalizar el tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pacientes ? 18 años con infección por el VIH.
    Presencia de cirrosis hepática por virus C (ARN-VHC en plasma positivo), genotipos 1 o 4, sin respuesta virológica del VHC a un tratamiento previo con dosis estándares de interferón pegilado alfa-2a o 2b y ribavirina.
    El grado de fibrosis hepática deberá estar evaluado mediante biopsia hepática y/o elastometría hepática transitoria (? 14 Kpa) realizado en los 3 meses previos a la inclusión. Asimismo, se admitirá el diagnóstico de cirrosis clínica.
    Ausencia de otras posibles causas de hepatitis crónica: virus B, virus D, hepatopatía alcohólica, déficit a-1 antitripsina, hemocromatosis hereditaria, enfermedad de Wilson, hepatitis autoinmune, cirrosis biliar primaria, y colangitis esclerosante primaria.
    Si el paciente está recibiendo tratamiento antirretroviral, éste debe ser estable y bien tolerado durante los últimos 3 meses previos a la inclusión y tener una viremia VIH (ARN-VIH-1) ?50 copias/mL y un recuento de linfocitos CD4+ >100/µL en el momento de inclusión en el estudio. Si el paciente no recibe tratamiento antirretroviral, el recuento de linfocitos CD4+ debe ser ?350/?L en el momento de inclusión en el estudio.
    Test de embarazo en orina negativo (para mujeres en edad fértil y que puedan quedar embarazadas). Además, estas pacientes deben usar un método contraceptivo efectivo durante el tratamiento. Ello no es necesario en mujeres esterilizadas quirúrgicamente o en estado de post-menopausia.
    Consentimiento informado del paciente.
    E.4Principal exclusion criteria
    ?Pacientes embarazadas o que no utilicen medios de contracepción seguros.
    ?Hepatitis crónica y/o cirrosis por VHC con genotipos diferentes del 1 y 4.
    ?Presencia de otras posibles causas de hepatitis crónica: virus B, virus D, hepatopatía alcohólica, déficit a-1 antitripsina, hemocromatosis hereditaria, enfermedad de Wilson, hepatitis autoinmune, cirrosis biliar primaria, y colangitis esclerosante primaria.
    ?Hemograma con cifras de neutrófilos <1000/?L, hemoglobina <100 g/L o plaquetas <20.000/?L.
    ?Aclaramiento de creatinina < 50 mL/min.
    ?Cirrosis hepática descompensada en el momento de la inclusión (ascitis, varices sangrantes, peritonitis, encefalopatía o hepatocarcinoma)
    ?Clasificación de severidad de enfermedad hepática de Child-Pugh >6 (contraindicación relativa: sólo si el médico responsable del paciente estima que los beneficios derivados de este tratamiento pueden superar los posibles efectos adversos y así lo haga constar el CDR)
    ?Transplante de órgano.
    ?Alcoholismo o consumo activo de drogas por vía iv. No se excluyen los pacientes incluidos en programas de mantenimiento con metadona.
    ?Tratamiento concomitante con inmunomodulares, o con estavudina, didanosina o zidovudina (contraindicación relativa).
    ?Existencia de un proceso psiquiátrico grave, en especial depresión grave e ideas o intento de suicidio.
    ?Enfermedades autoinmunes concomitantes.
    ?Cualquier paciente con riesgo elevado en el momento inicial de anemia (talasemia, esferocitosis, antecedentes de sangrado gastrointestinal, etc) o para los que la anemia podría ser médicamente un problema.
    ?Antecedentes de cualquier enfermedad cardiaca grave (p.ej.: clase III o IV, según Escala Funcional NYHA, infarto de miocardio en los 6 meses previos, taquicardia ventricular requiriendo tratamiento actual, angina inestable y otras enfermedades cardiovasculares importantes).
    ?Los pacientes con coronariopatía documentada o presuntiva o enfermedad cerebrovascular no deberán ser incluidos en el estudio si, a juicio del investigador, no pudieran tolerar adecuadamente una disminución aguda de la hemoglobina como puede llegar a producirse con el tratamiento de ribavirina.
    ?Antecedentes de padecer enfermedad grave o situación que, a juicio del investigador, incapacite al paciente para ser incluido en el estudio.
    ?Historia de enfermedad tiroidea no controlada adecuadamente.
    ?Evidencia de retinopatía grave (p.ej.: degeneración macular).
    ?Pacientes incapacitados para otorgar el consentimiento legal
    E.5 End points
    E.5.1Primary end point(s)
    Porcentaje de pacientes con respuesta viral sostenida (viremia VHC indetectable en plasma mediante PCR cualitativa) 24 semanas tras finalizar el 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 Yes
    E.6.7Pharmacodynamic Yes
    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 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 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 concerned4
    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 Information not present in EudraCT
    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
    Con los resultados de respuesta y efectos adversos de la mitad de los pacientes previstos en la inclusión tras 12 semanas de tratamiento, los investigadores se reunirán y valorarán dichos resultados. Sólo en caso de que la tasa de respuestas virales tempranas (RNA-VHC plasmático negativa o una disminución ? 2 log10 UI/mL respecto a la basal) sea inferior al 10%, se suspenderá el ensayo clínico. Este mismo procedimiento se realizará tras 12 semanas de tratamiento de todos los pacientes.
    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 months9
    E.8.9.1In the Member State concerned 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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-03-31. Yes
    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 state30
    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 Decision2009-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-07
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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