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    The EU Clinical Trials Register currently displays   43936   clinical trials with a EudraCT protocol, of which   7310   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:2012-004792-39
    Sponsor's Protocol Code Number:M12-999
    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:2013-03-05
    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 number2012-004792-39
    A.3Full title of the trial
    Open-label, Single Arm, Phase 2 Study to Evaluate the Safety and Efficacy of the Combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered with Ribavirin (RBV) in Adult Liver Transplant Recipients with Genotype 1 Hepatitis C Virus (HCV) Infection
    Estudio de fase 2, abierto, de un solo grupo, para evaluar la seguridad y la eficacia de la combinación de ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) y ABT-333 administrados junto con ribavirina (RBV) en
    adultos receptores de un trasplante hepático e infectados por el virus de la hepatitis C (VHC) de genotipo 1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Safety and Effect of three experimental drugs ABT?450, ABT-267 and ABT-333 in combination with Ribavirin in people who have had a Liver Transplant and have Hepatitis C Virus (HCV) infection. "Experimental" means that they have not been approved by any regulatory agency for sale to the public.
    Un estudio para evaluar la seguridad y eficacia de tres fármacos experimentales ABT- 450, ABT- 267 y ABT333 administrados junto con Ribavirina en personas con un transplante hepático y con infección crónica por el virus de la hepatitis C (VHC). "Experimental" significa que no han sido aprobados por ninguna agencia reguladora para su venta al público.
    A.4.1Sponsor's protocol code numberM12-999
    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 pointeuclinicaltrials@abbott.com
    B.5.3 Address:
    B.5.3.1Street AddressAbbott House, Vanwall Business Park, Vanwall
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628644475
    B.5.5Fax number+441628644330
    B.5.6E-maileuclinicaltrials@abbott.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-450/r/ABT-267
    D.3.2Product code ABT-450/r/ABT-267
    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-450
    D.3.9.2Current sponsor codeABT-450
    D.3.9.3Other descriptive nameABT-450
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITONAVIR
    D.3.9.1CAS number 155213-67-5
    D.3.9.2Current sponsor codeRITONAVIR
    D.3.9.4EV Substance CodeSUB10342MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABT-267
    D.3.9.2Current sponsor codeABT-267
    D.3.9.3Other descriptive nameABT-267
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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 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-333
    D.3.2Product code ABT-333
    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-333
    D.3.9.2Current sponsor codeABT-333
    D.3.9.3Other descriptive nameABT-333
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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.2.5The 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 nameRibavirin
    D.3.2Product code Ribavirin
    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 INNRIBAVIRIN
    D.3.9.1CAS number 36791-04-5
    D.3.9.2Current sponsor codeRIBAVIRIN
    D.3.9.3Other descriptive nameRIBAVIRIN
    D.3.9.4EV Substance CodeSUB10297MIG
    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) 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 C Infection
    Infección Crónica por el virus de la Hepatis C
    E.1.1.1Medical condition in easily understood language
    Chronic Hepatitis C Infection
    Infección Crónica por el virus de la Hepatis C
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10008912
    E.1.2Term Chronic hepatitis C
    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
    The primary objectives of this study are to assess safety and efficacy (the percentage of subjects achieving a 12-week sustained virologic response, SVR12 (HCV ribonucleic acid [RNA] < lower limit of quantification [LLOQ] 12 weeks following treatment) of coformulated ABT-450/r and ABT-267 (ABT-450/r/ABT-267) and ABT-333 coadministered with RBV for 24 weeks in HCV genotype 1-infected adult liver transplant recipients.
    Los objetivos principales de este estudio consisten en evaluar la seguridad y la eficacia (porcentaje de
    sujetos que logren una respuesta virológica mantenida a las 12 semanas, RVM12 (ácido ribonucleico (ARN) del VHC < límite inferior de cuantificación (LIC), 12 semanas después del tratamiento) de ABT-450 en formulación conjunta con ritonavir (r) y ABT-267 (ABT-450/r/ABT-267) y ABT-333 administrado conjuntamente con ribavirina (RBV) durante 24 semanas en receptores adultos de un trasplante hepático con infección recurrente por el VHC de genotipo 1.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to assess the percentage of subjects achieving a 24-week sustained virologic response, SVR24 (HCV RNA < LLOQ 24 weeks following treatment), the percentage of subjects with virologic failure during treatment, and the percentage of subjects with relapse post-treatment.
    Los objetivos secundarios de este estudio consisten en evaluar el porcentaje de sujetos con fracaso virológico durante el tratamiento, el porcentaje de sujetos que logren una respuesta virológica mantenida a las 24 semanas, RVM24 (ARN del VHC < LIC, 24 semanas después del tratamiento) y el porcentaje de sujetos con recidiva después del tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female between the ages of 18 and 70 years, inclusive, at time of enrollment.
    2. Liver transplantation as a consequence of HCV infection no less than 12 months before the Screening Visit.
    3. A liver biopsy which shows evidence of fibrosis ? F2 (Metavir scale) within 3 months prior to or during the Screening Period.
    4. Screening laboratory result indicating HCV genotype 1 infection.
    5. Currently taking an immunosuppressant regimen based on either tacrolimus or cyclosporine where doses of immunosuppressant drugs have not been increased over the 3 months prior to Screening and no new drugs have been added for at least 3 months before Screening. Corticosteroids such as prednisone or prednisolone are permitted as components of the immunosuppressant regimen providing the dose is not more than 5 mg/day.
    1. Varones o mujeres con una edad comprendida entre los 18 y 70 años, ambos inclusive, en el momento de inclusión.
    2. Trasplante hepático como consecuencia de la infección por el VHC no menos de 12 meses antes de la visita de selección.
    3. Biopsia hepática que revele datos de fibrosis ? F2 (escala de puntuación Metavir) en los 3 meses previos al período de selección o durante el mismo.
    4. Resultado analítico en la selección indicativo de una infección por el VHC de genotipo 1.
    5. Tratamiento presente con un régimen inmunosupresor a base de tacrolimus o ciclosporina en el que no se han aumentado las dosis de inmunosupresores durante los 3 meses previos a la selección y no se han añadido fármacos nuevos durante, al menos, 3 meses antes de la selección. Se permite el uso de corticosteroides, como prednisona o prednisolona, como componentes del régimen inmunosupresor, siempre que la dosis no sea superior a 5 mg/día.
    E.4Principal exclusion criteria
    - Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab).
    - Clinically significant abnormalities, other than HCV infection in a subject post transplant, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) that make the subject an unsuitable candidate for this study in the opinion of the investigator.
    - Recent (within 6 months prior to study drugs administration) history of drug or alcohol abuse that, in the opinion of the investigator, could preclude adherence to the protocol.
    - Previous use of any investigational or commercially available anti-HCV agent other than IFN-based therapy, i.e. conventional (c)IFN and/or pegylated (Peg) IFN, with or without RBV, including previous exposure to ABT-450, ABT-333 or ABT-267.
    - Resultado positivo en el análisis del antígeno de superficie del virus de la hepatitis B (HbsAg) o de anticuerpos contra el virus de la inmunodeficiencia humana (Ac anti-VIH).
    - Anomalías clínicamente importantes, aparte de la infección por el VHC, después del trasplante, basadas en los resultados de la anamnesis, la exploración física, las constantes vitales, las pruebas
    analíticas y un electrocardiograma (ECG) de 12 derivaciones que hacen que, en opinión del investigador, el sujeto no sea un candidato adecuado para este estudio.
    - Antecedentes recientes (en los 6 meses previos a la administración de los fármacos del estudio) de alcoholismo o toxicomanía que, en opinión del investigador, podrían impedir el cumplimiento del protocolo.
    - Uso previo de cualquier fármaco en investigación o comercializado contra el VHC distinto de un tratamiento a base de interferón (IFN), es decir, IFN convencional (IFNc) o pegilado (IFNpeg), con o sin RBV, incluida la exposición previa a ABT-450, ABT-333 o ABT-267.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the percentage of subjects with SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drugs).
    El criterio de valoración principal es el porcentaje de sujetos con RVM12 (ARN del VHC < LIC, 12 semanas después de la última dosis real de los fármacos del estudio).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after last dose of study drugs
    12 semanas después de la última dosis de los fármacos del estudio
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    ? The percentage of subjects with SVR24 (HCV RNA < LLOQ 24 weeks after the last actual dose of study drugs);
    ? The percentage of subjects with virologic failure during treatment;
    ? The percentage of subjects with post-treatment relapse.
    Los objetivos secundarios de este estudio consisten en evaluar:
    ? El porcentaje de sujetos con RVM24 (ARN del VHC < LIC 24 semanas después de la última dosis real de los fármacos del estudio);
    ? El porcentaje de sujetos con fracaso virológico durante el tratamiento;
    ? El porcentaje de sujetos con recidiva después del tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    Treatment Day 1 to end of treatment and end of treatment to 48 weeks post treatment.
    Desde el Día 1 de tratamiento hasta el final del tratamiento, y desde el final del tratamiento hasta 48 semanas después (Periodo Posterior al 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 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) 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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    United States
    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
    Last Subject Last Visit
    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 months6
    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 months6
    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: 25
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 5
    F.4.2.2In the whole clinical trial 30
    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)
    All subjects who receive at least one dose of direct acting antiviral agent (DAA) and who do not achieve and maintain virologic supression (HCV RNA less than lower limit of quantification), or who relapse post DAA therapy, may be offered participation in a separate, AbbVie-sponsored treatment study, or may be offered another off-study (non-AbbVie) treatment regimen, as determined appropriate by the investigator.
    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 Decision2013-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-13
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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