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    Summary
    EudraCT Number:2011-004724-35
    Sponsor's Protocol Code Number:VX-950HPC3006
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-004724-35
    A.3Full title of the trial
    Open-Label, Phase 3b Study To Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Genotype 1 Infected, Stable Liver Transplant Subjects
    Studio di fase 3b in aperto per determinare l'efficacia e la sicurezza di telaprevir, interferone pegilato-alfa-2a e ribavirina in soggetti stabili sottoposti a trapianto di fegato con infezione da epatite C di genotipo 1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An efficacy and safety study of Telaprevir in patients with genotype 1 Hepatitis C infection after liver transplantation
    Uno studio di efficacia e sicurezza su Telaprevir in pazienti con Epatite C di genotipo 1 dopo il trapianto di fegato
    A.3.2Name or abbreviated title of the trial where available
    REPLACE
    REPLACE
    A.4.1Sponsor's protocol code numberVX-950HPC3006
    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 SponsorJANSSEN-CILAG INTERNATIONAL N.V.
    B.1.3.4CountryBelgium
    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 supportJANSSEN CILAG SPA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31 071 524 21 66
    B.5.5Fax number+31 071 524 21 10
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 INCIVO
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN CILAG INTERNATIONAL NV
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 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 INNTELAPREVIR
    D.3.9.1CAS number 402957-28-2
    D.3.9.2Current sponsor codeVX-950
    D.3.9.4EV Substance CodeSUB31651
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number375
    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 Yes
    D.2.1.1.1Trade name PEGASYS*SC 1FL 180MCG/1ML
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 No
    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.3.9.1CAS number 198153-51-4
    D.3.9.4EV Substance CodeSUB16452MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number360
    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) 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 Yes
    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.2.1.1.1Trade name COPEGUS*28CPR RIV 200MG
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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.3.9.4EV 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
    Infezione da Epatite C cronica
    E.1.1.1Medical condition in easily understood language
    Chronic hepatitis C infection
    infezione da Epatite C cronica
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    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
    to determine the efficacy of telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in genotype 1 chronic HCV infected liver transplant patients as measured by sustained virologic response (SVR12planned). SVR12planned is defined as having an undetectable HCV ribonucleic acid (RNA) level 12 weeks after the last planned dose of study medication.
    L'obiettivo principale è determinare l'efficacia di telaprevir, somministrato con dosaggio di 750 mg ogni 8 ore in associazione a interferone pegilato (Peg-IFN)-alfa-2a e ribavirina (RBV) in soggetti sottoposti a trapianto di fegato con infezione cronica da HCV di genotipo 1, misurata dalla risposta virologica sostenuta (SVR12planned). Si parla di SVR12planned quando si riscontra una concentrazione di acido ribonucleico (RNA) dell'HCV non rilevabile 12 settimane dopo l'ultima dose programmata del trattamento dello studio
    E.2.2Secondary objectives of the trial
    . confrontare la percentuale di SVR ricavata in questo studio con una percentuale di SVR storica di controllo ricavata dalla letteratura su soggetti trattati con Peg-IFN ed RBV; • valutare le concentrazioni di HCV RNA e le risposte nel tempo, durante il trattamento e durante il follow-up; • valutare le variazioni istologiche della biopsia del fegato trapiantato confrontando l'ultima biopsia pre-trattamento con la biopsia eseguita 24 settimane dopo il trattamento; • valutare la sicurezza e la tollerabilità di telaprevir in associazione a Peg-IFN-alfa-2a, RBV e tacrolimus (TAC) o ciclosporina A (CsA); • valutare la farmacocinetica (PK) di telaprevir e le concentrazioni di TAC o CsA; • valutare i requisiti di titolazione della dose per TAC e CsA; • valutare l'incidenza del rigetto del fegato trapiantato;
    to compare the SVR rate from this study to a historical control SVR rate derived from the literature in subjects treated with Peg-IFN and RBV; - to evaluate HCV RNA levels and responses over time, on treatment and during follow-up; - to evaluate changes in liver graft biopsy histology comparing the last pre-treatment biopsy to the 24-week post-treatment biopsy; - to evaluate safety and tolerability of telaprevir in combination with Peg-IFN-alfa-2a, RBV, and tacrolimus (TAC) or cyclosporin A (CsA); - to evaluate the pharmacokinetics (PK) of telaprevir and concentrations of TAC or CsA; - to evaluate dose titration requirements for TAC and CsA; - to evaluate the incidence of liver graft rejection;
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female liver transplant recipient, 18 to 65 years old. 2. First time liver transplant recipient whose primary pre-transplant diagnosis was chronic hepatitis C and who is genotype 1 HCV RNA infected following transplantation. Genotype 1 must be confirmed during screening. 3. One of the following based on clinical history or by documented HCV RNA and treatment history: a) Treatment-naïve subject who did not receive any treatment with any approved or investigational medication or drug regimen for the treatment of HCV prior to liver transplantation; OR b) Treatment-experienced subject who received treatment for HCV prior to liver transplantation. Where documentation is available, treatment-experienced subjects who were treated with Peg-IFN/RBV and received 80% or more of the intended dose of Peg-IFN/RBV should be categorized based on their response as either: - Relapser: Subject had an undetectable HCV RNA level at the end of treatment (6 weeks or less after the last dose of medication) but did not achieve SVR; - Partial responder: Subject had a ≥ 2 log10 decrease in HCV RNA at approximately Week 12 of previous therapy, but never achieved undetectable HCV RNA while on treatment; - Null responder: Subject failed to decrease HCV RNA by  2 log10 after approximately 12 weeks of therapy. 4. > 12 months to 10 years post-liver transplant. 5. Subject must be on a stable TAC or CsA containing immunosuppressive regimen defined as no change in immunosuppressive agents and dose for 3 months prior to the screening visit. Low-dose prednisone (average daily dose ≤ 5 mg) being used as an immunosuppressant is allowed. Subject should not be on dual therapy with TAC and CsA, and combination treatment with mycophenolate mofetil (Cellcept) is not allowed. Subjects may not use any other immunosuppressive agents.
    1. Uomini o donne di età compresa tra 18 e 65 anni sottoposti a trapianto di fegato. 2. Soggetti sottoposti a trapianto di fegato per la prima volta con diagnosi principale pre-trapianto di epatite C cronica e con infezione da HCV RNA di genotipo 1 dopo il trapianto. Il genotipo 1 va confermato durante lo screening. 3. Una delle seguenti caratteristiche evidenziate dall'anamnesi clinica o dall'HCV RNA documentato e dall'anamnesi di trattamento: a) soggetti nuovi al trattamento che non hanno ricevuto alcun trattamento con farmaci o regimi terapeutici approvati o sperimentali per il trattamento dell'HCV prima del trapianto di fegato OPPURE b) soggetti già sottoposti a trattamento che hanno ricevuto un trattamento per l'HCV prima del trapianto di fegato. Nei casi in cui sia disponibile la documentazione necessaria, i soggetti già sottoposti a trattamento che erano stati trattati con Peg-IFN/RBV e avevano assunto l'80% o più della dose prevista di Peg-IFN/RBV devono essere classificati in base alla risposta, secondo le seguenti modalità: - soggetto con recidiva: soggetto che presentava una concentrazione di HCV RNA non rilevabile alla fine del trattamento (6 settimane o meno dopo l'ultima dose di trattamento) ma non ha ottenuto la SVR; - soggetto con risposta parziale: soggetto che presentava una riduzione ≥ 2 log10 dell'HCV RNA all'incirca alla Settimana 12 della terapia precedente ma non ha mai ottenuto una concentrazione di HCV RNA non rilevabile durante il trattamento; - soggetto senza risposta: soggetto che non ha ottenuto una riduzione dell'HCV RNA  2 log10 dopo circa 12 settimane di terapia. 4. Soggetti che hanno subito un trapianto di fegato in un perido compreso che va da più di 12 mesi a 10 anni. 5. Soggetti che assumono un regime stabile di immunosoppressori che includa TAC o CsA; per regime stabile si intende che non si sono verificate variazioni degli agenti immunosoppressori e della dose nei 3 mesi precedenti alla visita di screening. Il prednisone a basso dosaggio (dose giornaliera media ≤ 5 mg) utilizzato come immunosoppressore è consentito. I soggetti non possono assumere una doppia terapia con TAC e CsA; il trattamento di associazione con micofenolato mofetile (Cellcept) non è consentito. I soggetti non possono assumere altri agenti immunosoppressori.
    E.4Principal exclusion criteria
    Subject is infected or co-infected with non-genotype 1 HCV. 2. Subject received treatment with a direct acting antiviral for hepatitis C. 3. Subject received HCV treatment (approved or investigational medication) following liver transplantation. 4. Subject has histological evidence of rejection on the most recent liver graft biopsy obtained at screening or within 3 months (no serial liver graft biopsies taken) to 6 months (if serial liver graft biopsies have been taken) prior to the screening visit. 5. Subject has a contraindication to the administration of Peg-IFN-alfa or RBV, including but not limited to any of the following: - hypersensitivity to Peg-IFN-alfa, RBV, or any of their components; - hemoglobinopathies (including thalassemia major, sickle-cell disease);history or clinical evidence of significant or unstable cardiac disease (e.g., angina, congestive heart failure, recent (within 1 year) myocardial infarction, significant arrhythmia), and/or clinically significant ECG abnormalities; - abnormal thyroid function that is not adequately controlled; - poorly controlled diabetes mellitus as evidenced by hemoglobin A1c (HbA1c) ≥ 8.5% at screening; - antinuclear antibody (ANA) titer ≥ 1:640 at screening, evidence of autoimmune-mediated disease (e.g., Crohn’s disease, ulcerative colitis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis), and/or evidence of autoimmune hepatitis.
    1. Soggetti con infezione o coinfezione da HCV non di genotipo 1. 2. Soggetti che sono stati trattati con un antivirale ad azione diretta per l'epatite C. 3. Soggetti che hanno ricevuto un trattamento per l'HCV (con farmaci approvati o sperimentali) dopo il trapianto di fegato. 4. Soggetti con evidenza istologica di rigetto nella biopsia del fegato trapiantato più recente ottenuta allo screening o entro un periodo compreso tra 3 mesi (nessuna biopsia periodica del fegato trapiantato) e 6 mesi (precedente esecuzione di biopsie periodiche del fegato trapiantato) prima della visita di screening. 5. Soggetti con una controindicazione alla somministrazione di Peg-IFN-alfa o RBV, inclusa, a titolo esemplificativo, una qualsiasi delle seguenti controindicazioni: - ipersensibilità a Peg-IFN-alfa, RBV o a uno qualsiasi dei loro componenti; - emoglobinopatie (comprese talassemia maggiore e anemia falciforme); - anamnesi medica o evidenza clinica di cardiopatia significativa o instabile (ad es., angina, insufficienza cardiaca congestizia, recente infarto del miocardio [entro 1 anno], aritmia significativa) e/o anomalie clinicamente significative dell'ECG; - funzionalità tiroidea alterata non adeguatamente controllata; - diabete mellito non ben controllato, dimostrato da emoglobina A1c (HbAlc) ≥ 8,5% allo screening; - titolo anticorpale anti-nucleo (ANA) ≥ 1:640 allo screening, evidenza di altra malattia autoimmune (ad es., morbo di Crohn, colite ulcerosa, porpora trombocitopenica idiopatica, lupus eritematoso sistemico, anemia emolitica autoimmune, scleroderma, psoriasi grave) e/o evidenza di epatite autoimmune.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels.
    Percentuale di pazienti che ottengono livelli di HCV RNA nel plasma non rilevabili
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after the last planned dose of study drugs
    12 settimane dopo l'ultima dose programmata dei farmaci in studio
    E.5.2Secondary end point(s)
    Proportion of subjects achieving SVR24planned, defined as having an undetectable plasma HCV RNA level 24 weeks after the last planned dose of study medication. o Proportion of subjects having an undetectable HCV RNA level at Week 4 of treatment (RVR). o Proportion of subjects having an undetectable HCV RNA level at Week 12 of treatment. o Proportion of subjects having undetectable HCV RNA levels at Week 4 and Week 12 of treatment (eRVR). o Proportion of subjects having an undetectable HCV RNA level at the actual end of treatment (i.e., Week 48 or early discontinuation). o Proportion of subjects having an undetectable HCV RNA level at the planned end of treatment (i.e., Week 48). o Proportion of subjects having < 25 IU/mL at the planned end of treatment (i.e., Week 48). o Proportion of subjects with on-treatment virologic failure (subjects who meet a virologic stopping rule and/or meet the definition of viral breakthrough). o Proportion of subjects who relapse, defined as having confirmed detectable HCV RNA during the follow-up period after previous undetectable HCV RNA (< 25 IU/mL, undetectable) at actual end of treatment (i.e., Week 48 or early discontinuation). o Proportion of subjects who relapse, defined as having confirmed detectable HCV RNA during the follow-up period after previous undetectable HCV RNA (< 25 IU/mL, undetectable) at planned end of treatment (i.e., Week 48). o Proportion of subjects who relapse, defined as having confirmed detectable HCV RNA during the follow-up period after previous HCV RNA < 25 IU/mL at planned end of treatment (i.e., Week 48). o Proportion of subjects with viral breakthrough (defined as an increase > 1 log in HCV RNA level from the lowest level reached, or a value of HCV RNA > 100 IU/mL in subjects whose HCV RNA has previously become < 25 IU/mL during treatment). o Change from baseline in log HCV RNA values at each time point during treatment. o Proportion of subjects who have changes in liver graft biopsy histology.
    o la percentuale di soggetti che ottengono l’SVR24planned, ossia una concentrazione plasmatica non rilevabile di HCV RNA 24 settimane dopo l’ultima dose programmata di trattamento dello studio; o la percentuale di soggetti con concentrazione non rilevabile di HCV RNA alla Settimana 4 di trattamento (RVR); o la percentuale di soggetti con concentrazione non rilevabile di HCV RNA alla Settimana 12 di trattamento; o la percentuale di soggetti con concentrazione non rilevabile di HCV RNA alla Settimana 4 e alla Settimana 12 di trattamento (eRVR); o la percentuale di soggetti con concentrazione non rilevabile di HCV RNA alla conclusione effettiva del trattamento (cioè Settimana 48 o interruzione anticipata); o la percentuale di soggetti con concentrazione non rilevabile di HCV RNA alla conclusione programmata del trattamento (cioè Settimana 48); o la percentuale di soggetti con < 25 IU/ml alla conclusione programmata del trattamento (cioè Settimana 48); o la percentuale di soggetti con fallimento virologico durante il trattamento (soggetti che soddisfano una regola di interruzione virologica e/o soddisfano la definizione di breakthrough virale); o la percentuale di soggetti con recidiva, ossia concentrazione non rilevabile di HCV RNA confermata durante la fase di follow-up dopo una precedente concentrazione non rilevabile di HCV RNA (< 25 IU/ml, non rilevabile) alla conclusione effettiva del trattamento (ossia Settimana 48 o interruzione anticipata); o la percentuale di soggetti con recidiva, ossia concentrazione non rilevabile di HCV RNA confermata durante la fase di follow-up dopo una precedente concentrazione non rilevabile di HCV RNA (< 25 IU/ml, non rilevabile) alla conclusione programmata del trattamento (ossia Settimana 48); o la percentuale di soggetti con recidiva, ossia concentrazione non rilevabile di HCV RNA confermata durante la fase di follow-up dopo una precedente concentrazione di HCV RNA < 25 IU/ml alla conclusione programmata del trattamento (ossia Settimana 48); o la percentuale di soggetti con breakthrough virale (definita come un aumento > 1 log della concentrazione di HCV RNA dal livello minimo raggiunto o un valore di HCV RNA > 100 IU/ml nei soggetti la cui concentrazione di HCV RNA era precedentemente diventata < 25 IU/ml durante il trattamento); o la variazione dei valori log dell'HCV RNA rispetto al basale a ogni data durante il trattamento; o la percentuale di soggetti che presentano alterazioni istologiche della biopsia del fegato trapiantato.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 24 weeks after last planned dose of study drugs - actual end of study drugs - week 48 of study drugs - follow-up period after previous undetectable HCV RNA levels at actual end of study drugs - follow-up period after previous undetectable HCV RNA levels at week 48 - follow up period after previous undetectable HCV RNA levels at week 48 - from day 1 till week 48
    24 settimane dopo l'ultima dose programmata dei farmaci in studio - data effettiva di interruzione dei farmaci - la settimane nr. 48 - periodo di follow up dopo i precedenti livelli non rilevabili di HCV RNA alla data effettiva di interruzione dei farmaci - periodo di follow up dopo i precedenti livelli non rilevabili di HCV RNA alla settimana 48 - dal giorno 1 fino alla settimana 48
    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 No
    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 No
    E.6.11Pharmacogenomic Yes
    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.8.2.4Number of treatment arms in the trial1
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    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.1.1Number of subjects for this age range: 0
    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: 8
    F.1.3Elderly (>=65 years) No
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 72
    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)
    NAP
    NAP
    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 Decision2012-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-15
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