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    Summary
    EudraCT Number:2012-004138-41
    Sponsor's Protocol Code Number:TEL-PR
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-10-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-004138-41
    A.3Full title of the trial
    Anti-viral T cell responses in patients with chronic HCV infection treated with telaprevir: can therapy induce functional T cell reconstitution?
    Risposte T-linfocitarie HCV-specifiche in pazienti con epatite cronica C trattati con Telaprevir: la funzione anti-virale linfocitaria può essere ripristinata dalla terapia?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can protective T cell responses be improved by telaprevir therapy in patients with chronic hepatitis C who have deeply inhibited HCV-specific T cells?
    Le risposte proteggenti dei linfociti T possono essere migliorate dalla terapia con telaprevir nei pazienti con infezione cronica C in cui tali risposte sono di base profondamente depresse?
    A.3.2Name or abbreviated title of the trial where available
    Analysis of HCV-specific T cell function
    Analisi della funzione T-linfocitaria HCV-specific
    A.4.1Sponsor's protocol code numberTEL-PR
    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 SponsorAZIENDA OSPEDALIERA DI PARMA
    B.1.3.4CountryItaly
    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 supportJANSSEN-CILAG
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliero-Universitaria di Parma
    B.5.2Functional name of contact pointSegreteria Comitato Etico
    B.5.3 Address:
    B.5.3.1Street Addressvia Gramsci 14
    B.5.3.2Town/ cityParma
    B.5.3.3Post code43126
    B.5.3.4CountryItaly
    B.5.4Telephone number0521704775
    B.5.5Fax number0521704702
    B.5.6E-mailgideluca@ao.pr.it
    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
    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 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.3.9.2Current sponsor codeTELAPREVIR
    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 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 REBETOL*140CPS 200MG
    D.2.1.1.2Name of the Marketing Authorisation holderMSD ITALIA Srl
    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 Capsule
    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.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 PEGASYS*SC PEN 0,5ML 180MCG
    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 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) 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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeprodotta attraverso la tecnica del DNA ricombinante nell’Escherichia coli e coniugata
    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 active hepatitis C never treated previously with anti-HCV therapies
    Epatite cronica attiva da virus dell’epatite C (HCV) mai precedentemente sottoposti a terapie anti-virali per HCV
    E.1.1.1Medical condition in easily understood language
    Chronic active hepatitis C never treated previously with anti-HCV therapies
    Epatite cronica attiva da virus dell’epatite C (HCV) mai precedentemente sottoposti a terapie anti-virali per HCV
    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 PT
    E.1.2Classification code 10019744
    E.1.2Term 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 characterize the effect of telaprevir therapy on adaptive immune responses in patients with chronic hepatitis C assessing: - whether viral suppression and decline of antigenemia induced by antiviral therapy are associated with a progressive restoration of antiviral T cell functions; - to what extent functional reconstitution results in maturation of fully differentiated effector and memory T cells, as observed after spontaneous control of HCV infection; - whether a hierarchical restoration of different T cell functions occurs over time upon viral control in individual patients; - whether the emergence of HCV mutants resistant to therapy can impair anti-viral T cell responses; - whether different levels of efficiency of pre-treatment antiviral T cell responses can predict response to treatment
    Caratterizzare l'effetto della terapia antivirale con Telaprevir sulle risposte immunitarie adattative proteggenti in pazienti con epatite cronica C valutando: - se la soppressione virale ed il declino del antigenemia sono associati ad un ripristino delle funzioni antivirali dei linfociti T HCV-specifici; - in che misura la ricostituzione immunologica conduca alla maturazione di linfociti T in termini di memoria e di funzioni effettrici, - se il ripristino funzionale T linfocitario si realizzi in modo progressivo e gerarchico in funzione del tempo di soppressione virale; - se le risposte T-linfocitarie siano influenzate dall’emergenza di varianti virali resistenti alla terapia - se il livello di efficienza delle risposte T linfocitarie HCV-specifiche espresso prima dell’inizio del trattamento possa predire la risposta al trattamento stesso
    E.2.2Secondary objectives of the trial
    To assess whether pre-treatment T cell responses can predict the final outcome of therapy
    Valutare se le risposte T linfocitarie espresse prima dell’inizio della terapia possano predirne l’esito finale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Be a man or woman between 18 and 70 years of age • Sign the informed consent document indicating that they understand the purpose of and procedures required for the immunological study • Have evidence of HCV infection with genotype 1 (molecular assay) diagnosed at least 6 months before the baseline • Have documented mild or moderate liver fibrosis (Metavir F0-F2 or Ishak 0-2) assessed by liver biopsy in the past 12 months • Have a favorable IL28B genotype (CC) • BMI < 30 • Absence of contraindications to pegInterferon and ribavirine • If a women of childbearing potential, must have a negative serum  human chorionic gonadotropin ( hCG) or urine pregnancy test documented at the screening visit and a negative serum or urine pregnancy test before the first dose of study drug to ensure that they are not pregnant at the time of starting treatment. • If heterosexually active, a female subject of childbearing potential and a nonvasectomized male subject who has a female partner of childbearing potential must agree to use 2 effective contraceptives from screening onwards until 4 months (female subject) or 7 months (male subject) after RBV therapy has ended.
    • Uomini e donne di età compresa tra 18 e 70 anni • Firma del consenso informato • Diagnosi di epatite cronica da HCV di genotipo 1 diagnosticata almeno 6 mesi prima del baseline (giorno 1), in soggetti mai precedentemente sottoposti a trattamento antivirale specifico con pegInterferone e ribavirina (pazienti naive) con: - positività degli anticorpi anti-HCV e positività di HCV-RNA almeno sei mesi prima del baseline (giorno 1) e - biopsia epatica effettuata non più di 12 mesi prima del baseline (giorno 1) con assenza di fibrosi severa • Presenza di parametri predittivi di risposta alla terapia anti-virale al baseline (genotipo CC di IL 28, presenza di fibrosi lieve o moderata alla biopsia epatica, Metavir F0-F2 o Ishak 0-2) • BMI &lt; 30 • Assenza di controindicazioni a pegInterferone e ribavirina  In caso di donna fertile, -HCG negativo allo screening e test di gravidanza delle urine negativo, eseguito nelle 24 ore precedenti la prima somministrazione dei farmaci in studio.  Uso di metodi anticoncezionali efficaci per donne in età fertile e nelle partner di pazienti maschi in età fertile (almeno due metodi contraccettivi efficaci, uno dei quali rappresentato da condom con spermicida) per tutta la durata della terapia e nei 7 mesi successivi
    E.4Principal exclusion criteria
    • Pregnant woman or woman who wants to become pregnant during the course of the study • Infected or coinfected with HCV of a genotype other than genotype 1 • CT or TT genotype of IL28, presence of severe fibrosis at the liver biopsy (Metavir > 2 o Ishak > 2) • History of hemoglobinopathy, sarcoidosis, invasive neoplasia diagnosed or treated in the previous 5 years • History of severe psychiatric disease, including psychosis and/or depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease • Co-infection with HBV or HIV • Chronic use of systemic immunepressive agents • Presence of autoimmune disorders; patients with hypothyroidism and normal TSH can be enrolled • History of severe heart or chronic pulmonary diseases • History of solid organ transplantation • Suspected hepatocellular carcinoma • Alcohol or drug abuse
    • Donne incinte o donne che possono desiderare di diventare incinte durante il corso dello studio • Soggetti di sesso maschile con partner incinta o che sta progettando di diventare incinta entro sette mesi dall’ultima dose di ribavirina • Evidenza di infezione o di co-infezione con HCV di genotipo non 1 • IL28 genotipo CT o TT, presenza di fibrosi severa alla biopsia epatica (Metavir &gt; 2 o Ishak &gt; 2) • Storia di emoglobinopatia • Storia di sarcoidosi • Storia di neoplasia invasiva diagnosticata o trattata nei 5 anni precedenti. • Malattie psichiatriche non trattate o significative, quali depressione severa, schizofrenia, psicosi, storia di tentato suicidio • Co-infezione con HBV o HIV • Uso cronico di agenti immunosopressivi sistemici • Presenza di disordini autoimmuni;soggetti con ipotiroidismo trattato e TSH normale possono essere arruolati • Storia di malattia cardiaca significativa • Evidenza clinica di malattia polmonare cronica • Storia di trapianto di organo solido • Sospetto di carcinoma epatocellulare • Patologia epatica cronica di eziologia non HCV • Abuso di alcool in atto • Storia di abuso rilevante di droga
    E.5 End points
    E.5.1Primary end point(s)
    Generation of novel information about the immune mechanisms of anti-viral control in HCV infection in the perspective of novel immune therapies
    Acquisizione di nuove conoscenze sui meccanismi di controllo immunologico dell’infezione da HCV nella prospettiva di nuove terapie immunomodulanti
    E.5.1.1Timepoint(s) of evaluation of this end point
    Two years
    Due anni
    E.5.2Secondary end point(s)
    Generation of novel information about the mechanisms of action through which telaprevir can inhibit HCV replication
    Acquisizione di nuove conoscenze sui meccanismi d’azione con cui telaprevir inibisce la replicazione di HCV
    E.5.2.1Timepoint(s) of evaluation of this end point
    Two years (24 months)
    Due anni (24 mesi)
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Characterization of functional T cell restoration during anti-viral therapy
    Caratterizzazione dei meccanismi di recupero funzionale T-linfocitario in corso di terapia antiviral
    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 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 No
    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.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 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 months24
    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.1.1Number 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: 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 state30
    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)
    Completion of the laboratory immunological-virological study
    completamento dello studio immuno/virologico laboratoristico
    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 Decision2012-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-09-15
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