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    Summary
    EudraCT Number:2015-005616-14
    Sponsor's Protocol Code Number:M13-596
    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:2016-02-17
    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 number2015-005616-14
    A.3Full title of the trial
    A Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients with Chronic Hepatitis C Virus Genotype 1 ? 6 Infection (MAGELLAN-2)
    Estudio abierto y de un solo grupo para evaluar la seguridad y la eficacia de ABT-493/ABT-530 en adultos que han sido receptores de un trasplante hepático o renal, con infección crónica por el virus de la hepatitis C (VHC) genotipos 1-6 (MAGELLAN-2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Post-liver or Post-kidney transplant with Chronic Hepatitis C Virus
    Estudio para evaluar la Eficacia y Seguridad de ABT-493/ABT-530 tras trasplante hepático o renal con virus de la hepatitis C crónico
    A.4.1Sponsor's protocol code numberM13-596
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbvie Ltd.
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628561090
    B.5.5Fax number+34901200103
    B.5.6E-mailabbvie_reec@abbvie.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 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 nameABT-493/ABT-530
    D.3.2Product code ABT-493/ABT-530
    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 INNABT-493
    D.3.9.2Current sponsor codeABT-493
    D.3.9.3Other descriptive nameABT-493
    D.3.9.4EV Substance CodeSUB131084
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABT-530
    D.3.9.2Current sponsor codeABT-530
    D.3.9.3Other descriptive nameABT-530
    D.3.9.4EV Substance CodeSUB131083
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Hepatitis C Virus
    Virus Hepatitis C
    E.1.1.1Medical condition in easily understood language
    HCV Genotypes 1-6
    VHC Genotipo 1-6
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    The primary objectives of this study are to assess the efficacy (12-week sustained virologic response, SVR12 [HCV RNA < LLOQ 12 weeks following therapy]) of 12 weeks of treatment with the ABT-493/ABT-530 combination regimen in adults with HCV genotype GT1 ? 6 infection who are DAA-naïve and post primary orthotopic liver transplant or renal transplant and to assess the safety of treatment with the ABT-493/ABT-530 combination regimen for 12 weeks in adults with HCV genotype GT1 ? 6 infection and post primary orthotopic liver transplant or renal transplant.
    El objetivo primario de este estudio es evaluar la eficacia (respuesta virológica sostenida a las 12 semanas, RVS12 [ARN VHC < LLOQ 12 semanas tras la terapia] de 12 semanas de tratamiento con un régimen combinado de ABT-493/ABT-530 en adultos con infección por VHC genotipos del 1 al 6 y trasplante hepático primario o trasplante renal.
    E.2.2Secondary objectives of the trial
    ? Efficacy (the percentage of subjects with SVR12) among all HCV genotype GT1 ? 6 infected subjects who are post primary orthotopic liver transplant or renal transplant treated for 12 weeks.
    ? The percentages of subjects with on-treatment virologic failure.
    ? The percentages of subjects with post-treatment relapse.
    ? Eficacia (el porcentaje de pacientes con RVS 12) entre todos los pacientes infectados por VHC genotipos del 1 al 6 con trasplante hepático primario o trasplante renal tratados durante 12 semanas.
    ? El porcentaje de pacientes con fallo virológico en tratamiento.
    ? El porcentaje de pacientes con recaida postrasplante
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    optional pharmacogenetic
    Farmacogenética opcional
    E.3Principal inclusion criteria
    1. Male or female, at least 18 years of age at time of screening.
    2. Screening laboratory result indicating HCV GT1 ? 6 infection.
    3. Subject is a recipient of a cadaveric or living donor liver transplant which was a consequence of HCV infection ? 3 months prior to screening Or Subject received a cadaveric or living donor kidney at least ? 3 months before screening.
    4. Subjects must be documented as non-cirrhotic.
    5. Subject is currently taking a stable immunosuppression regimen based on tacrolimus, sirolimus, everolimus, mycophenolate mofetil , azathioprine, or cyclosporine.
    1. Hombres o mujeres, de al menos 18 años de edad en el momento de la seleccion
    2. Resultado de laboratorio en selección indicando infección por VHC GT1-6
    3. El paciente es un receptor de un trasplante de hígado de donante vivo o muerto como consecuencia de la infección por VHC > 3 meses de la selección o el paciente recibió un riñon de donante vivo o muerto al menos > 3 meses antes de la selección.
    4. Los pacientes deben ser documentados como no-cirróticos
    5. El paciente está actualmente bajo un régimen inmunosupresivo estable basado en tacrolimus, sirolimus, everolimus, mofetil micofenolato , azatioprina, o ciclosporina.
    E.4Principal exclusion criteria
    1. Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug.
    2. Clinical history of fibrosing cholestatic hepatitis post-transplant.
    3. Re-transplantation of the liver or kidney.
    4. Steroid resistant rejection of the transplanted liver or kidney, or a history of rejection treated with high dose steroid within 3 months of screening.
    5. History of post-transplant complications related to hepatic or renal vasculature.
    1. Mujeres embarazadas, amamantando o que se considera que van a quedarse embarazadas durante el estudio o aproximadamente 30 dias tras la última dosis de la medicación del estudio.
    2. Historia clínica de hepatitis colestásica fibrosante.
    3. Re-trasplante de hígado o riñon
    4. Rechazo resistente a esteroides del hígado o del riñón trasplantado, o una historia de rechazo tratados con esteroides alta dosis dentro de los 3 meses de seleccion.
    5. Historia de complicaciones post-trasplante relacionados con la vasculatura hepática o renal.
    E.5 End points
    E.5.1Primary end point(s)
    ? The percentage of subjects with SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug) for all DAA-naïve subjects treated with ABT-493/ABT-530.
    ? El porcentaje de pacientes con RVS12 (ARN VHC < LLOQ 12 semanas tras la ultima dosis de la medicacion de studio) para todos los pacientes AAD-naïve tratados con ABT-493/ABT-5
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks following the last dose of study drug
    12 semanas tras la última dosis de la medicación del estudio
    E.5.2Secondary end point(s)
    ? The percentage of subjects achieving SVR12 among all subjects treated with ABT-493/ABT-530
    ? The percentage of subjects with on-treatment virologic failure for subjects treated with ABT-493/ABT-530,
    ? The percentage of subjects with post-treatment relapse for subjects treated with ABT-493/ABT-530.
    ? El porcentaje de pacientes que alcancen la RVS12 entre todos los pacientes tratados con ABT-493/ABT-530
    ? El porcentaje de pacientes con fallo virológico en tratamiento para pacientes tratados con ABT-493/ABT-530
    ? El porcentaje de pacientes con recaida postrasplante para pacientes tratados con ABT-493/ABT-530
    E.5.2.1Timepoint(s) of evaluation of this end point
    ? 12 weeks following the last dose of study drug
    ? Treatment Day 1 to end of treatment
    ? End of treatment to 24 weeks post treatment.
    ? 12 semanas tras la última dosis de la medicación de estudio
    ? Tratamiento dia 1 hasta el final del tratamiento
    ? Final del tratamiento hasta la semana 24 postratamiento
    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 No
    E.6.10Pharmacogenetic Yes
    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) Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Australia
    Canada
    New Zealand
    Taiwan
    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
    LVLS
    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 months3
    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 months3
    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: 63
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 70
    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)
    Subjects will receive ABT-493/ABT-530 throughout the Treatment Period for 12 weeks or until premature discontinuation of study drug, followed by a 24 week Post-Treatment Period. discuss the appropriate subsequent treatment with the subject.

    AbbVie will not provide commercially available drug or any other therapy once the subject's participation is concluded.
    Los pacientes recibirán ABT-493/ABT-530 durante todo el periodo de tratamiento de 12 semanas o hasta discontinuación prematura de la medicación de estudio, tras un periodo de 24 semanas de postratamiento discutir el tratamiento subsecuente con el paciente.
    Abbvie no proporcionara la medicación disponible comercialmente u otro tipo de terapia una vez que la participación del paciente ha concluido.
    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 Decision2016-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-06-29
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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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