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    Summary
    EudraCT Number:2014-002317-32
    Sponsor's Protocol Code Number:SOFOLT-2
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-09-26
    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 number2014-002317-32
    A.3Full title of the trial
    An Open-Label Study to Explore the Clinical Efficacy of GS 7977 (Sofosbuvir -Sovaldi®) with Ribavirin as Pre-Emptive Administration in Transplant-Recipients with Hepatitis C Virus (HCV) active infection
    Valutazione dell’efficacia clinica di Sofosbuvir e Ribavirina nel trattamento pre-emptive in riceventi di trapianto di fegato con infezione HCV attiva.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Efficacy of Sofosbuvir with Ribavirin as Pre-Emptive Administration in Transplant-Recipients with Hepatitis C Virus (HCV) active infection
    Efficacia clinica di Sofosbuvir e Ribavirina come prevenzione in riceventi di trapianto di fegato con infezione HCV attiva.
    A.4.1Sponsor's protocol code numberSOFOLT-2
    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 Papa Giovanni XXIII
    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 supportGilead
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliera Papa Giovanni XXIII
    B.5.2Functional name of contact pointStefano Fagiuoli
    B.5.3 Address:
    B.5.3.1Street AddressPiazza OMS,1
    B.5.3.2Town/ cityBergamo
    B.5.3.3Post code24121
    B.5.3.4CountryItaly
    B.5.4Telephone number00390352674259
    B.5.5Fax number-----------------------------------------
    B.5.6E-mailsfagiuoli@hpg23.it
    B.Sponsor: 2
    B.1.1Name of SponsorAISF (Associazione Italiana per lo Studio del Fegato)
    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 supportGilead
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAISF
    B.5.2Functional name of contact pointFagiuoli
    B.5.3 Address:
    B.5.3.1Street AddressPiazza OMS,1
    B.5.3.2Town/ cityBergamo
    B.5.3.3Post code24121
    B.5.3.4CountryItaly
    B.5.4Telephone number00390352674259
    B.5.5Fax number---------------------------
    B.5.6E-mailsfagiuoli@hpg23.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 Sovaldi
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameSofosbuvir
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Copegus- Rebetol- Ribavirina Sandoz- Ribavirina Teva
    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.3.1Product nameRibavirina
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    HCV active infection at the time of OLT
    trapianto epatico in paziente con infezione HCV-correlata attiva
    E.1.1.1Medical condition in easily understood language
    Hepatitis C virus active infection at the time of liver's trasplant
    trapianto epatico in paziente con infezione del virus dell'epatite C attiva
    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
    To determine if the administration of a combination of GS 7977 and ribavirin to post-OLT HCV subjects for 24 weeks can prevent post-transplant HCV re-infection as determined by a sustained post-transplant virological response (HCV RNA <LLoQ) at 12 weeks post-transplant
    L’obiettivo primario dello studio è valutare se la somministrazione della combinazione GS 7977 (Sovaldi®) e Ribavirina nell’immediato post-operatorio a pazienti sottoposti a trapianto per malattia epatica HCV-correlata può prevenire la reinfezione del graft definite come risposta virologica sostenuta (SVR) (HCV RNA <LLoQ) a 12 settimane post-trapianto
    E.2.2Secondary objectives of the trial
    • Effect of treatment on HCV-related liver disease histology at 1-year
    • To evaluate the HCV RNA viral kinetics during the initial treatment phase (2 weeks, 4 weeks, 8 weeks) and correlation with response rate
    Evaluate, from the perspective of the Italian NHS, the overall healthcare cost of the pre-emptive treatment with sofosbuvir and ribavirin of post- LT HCV patients during the observational period. The collectionof these data will allow to compare, in a descriptive way, these costs vs those of patients, with similar characteristics, treated according the current routine practice.
    • Effetto del trattamento sul quadro istologico epatico ad 1 anno dal trapianto
    • Cinetica di HCV RNA durante le fasi iniziali del trattamento e sua correlazione con il tasso di risposta e breaktrough
    • Valutare i costi associati al trattamento dei pazienti nel periodo di osservazione nella prospettiva del Servizio Sanitario Nazionale. La rilevazione dei dati permetterà di confrontare, secondo una modalità descrittiva, i costi sostenuti per il trattamento pre-emptive con sofosbuvir/ribavirina rispetto ai costi di trattamento secondo l’attuale pratica clinica di pazienti con caratteristiche simili.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Males or females, age > 18 years old
    -All transplant patients with HCV active infection at the time of OLT
    -All genotypes
    Maschi o femmine, di età> 18 anni
    -Tutti i pazienti trapiantati con HCV infezione attiva al momento della OLT
    Tutti i genotipi
    E.4Principal exclusion criteria
    -Patients unable to receive oral therapy
    -< 6 months from previous DAA treatment
    -CrCl <30ml/min (MDRD or CKD-EPI)
    -HIV and/or HBV coinfection
    -I pazienti non in grado di ricevere una terapia orale
    - <6 mesi dal precedente trattamento DAA
    - CrCl <30 ml / min (MDRD o CKD-EPI)
    - HIV e / o HBV coinfezione
    E.5 End points
    E.5.1Primary end point(s)
    •Post-treatment sustained virological response (pTVR): SVR12
    Risposta virologica sostenuta post-trattamento alla settimana 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 week
    12 settimane
    E.5.2Secondary end point(s)
    •Post-treatment sustained virological response (pTVR): SVR24;
    •Histology at 1-year post-OLT
    •Healthcare resource consumption due to drug treatments, diagnostic services, specialist visits, lab tests, hospitalisations)
    •Risposta virologica sostenuta post-trattamento (pTVR): SVR24;
    Istologia epatica ad 1 anno post-trapianto
    •Consumo di risorse per le prestazioni assistenziali erogate ai pazienti (terapia farmacologica, test diagnostici, visite specialistiche, analisi di laboratorio, ospedalizzazioni)
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 week
    24 settimane
    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 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 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.8.3 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 concerned12
    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
    yes
    si
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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) No
    F.1.2.1Number of subjects for this age range: 45
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    none
    nessuno
    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 Decision2014-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-02
    P. End of Trial
    P.End of Trial StatusOngoing
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