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    Summary
    EudraCT Number:2011-006131-38
    Sponsor's Protocol Code Number:CDEB025A2312
    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:2012-06-21
    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 number2011-006131-38
    A.3Full title of the trial
    A multi-centre 3-year follow-up study to assess the durability of sustained virologic response in Alisporivirtreated chronic Hepatitis C patients
    Studio multicentrico di follow-up della durata di 3 anni per valutare la persistenza della risposta virologica sostenuta nei pazienti con epatite cronica C trattati con Alisporivir
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 3-year follow-up study of chronic hepatitis C patients treated with alisporivir to assess durability of sustained virologic response
    Studio di follow-up della durata di 3 anni per valutare la risposta virologica sostenuta nei pazienti con epatite cronica C trattati con Alisporivir
    A.4.1Sponsor's protocol code numberCDEB025A2312
    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 SponsorNOVARTIS FARMA
    B.1.3.4CountryItaly
    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 supportNOVARTIS
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farma
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Addresslargo Umberto Boccioni, 1
    B.5.3.2Town/ cityOriggio
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 02 96541
    B.5.5Fax number+39 02 9659066
    B.5.6E-mailinfo.studiclinici@novartis.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 nameAlisporivir
    D.3.2Product code DEB025
    D.3.4Pharmaceutical form Capsule, soft
    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.3.9.1CAS number 25443509505
    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 in patients who achieved sustained virologic response (SVR24) on alisporivir in a Novartis-sponsored chronic Hepatitis C study.
    persistenza della risposta virologica sostenuta in pazienti con epatite cronica C trattati con Alisporivir
    E.1.1.1Medical condition in easily understood language
    Chronic hepatitis C in patients who achieved sustained virologic response on alisporivir in a previous Novartis-sponsored trial.
    epatite cronica C in pazienti con persistente risposta virologica sostenuta trattati con Alisporivir che hanno partecipato a precedenti protocolli Novartis con alisporivir.
    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 assess the durability of sustained virologic response after SVR24 has been achieved in patients treated with alisporivir in a Novartissponsored chronic Hepatitis C study.
    Obiettivo primario: valutare la persistenza nel tempo della risposta virologica sostenuta nei pazienti che hanno raggiunto l’SVR24 dopo trattamento con alisporivir durante un precedente studio Novartis nell’epatite cronica C.
    E.2.2Secondary objectives of the trial
    -To determine whether subsequent detection of HCV RNA in patients who relapse following SVR24, represents the re-emergence of preexisting virus, the development of resistance mutations, or whether it is due to re-infection. -To assess the impact of successful alisporivir treatment on the change in liver disease over time and to assess the development of hepatocellular carcinoma (HCC). -To assess the safety over time of previous alisporivir exposure.
    •Determinare se l’eventuale HCV RNA misurabile nei pazienti che avevano raggiunto l’SVR24 rappresenti una nuova emergenza del virus preesistente oppure sia dovuto allo sviluppo di resistenze o ad una nuova infezione.•Valutare nel tempo le modifiche di malattia epatica nei pazienti che hanno raggiunto l’SVR24 in un precedente studio con alisporivir.•Valutare lo sviluppo di carcinoma epatocellulare•Valutare la sicurezza nel tempo della precedente esposizione del paziente ad alisporivir.Per maggiori dettagli consultare il capitolo 3 del protocollo originale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Written informed consent must be obtained before any assessment is performed -Males or females must be aged 18 years or older -Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir -Have achieved SVR24 -Be able to comply with visit schedule
    criteri di inclusione principali • Donne e uomini maggiorenni che abbiano firmato il consenso informato prima di qualsiasi valutazione prevista dallo studio • Pazienti che hanno partecipato ad un precedente studio sponsorizzato Novartis e hanno ricevuto alisporivir • Pazienti che hanno raggiunto l’SVR24
    E.4Principal exclusion criteria
    -Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer XML File Identifier: K6aU06lo1HleGgyLeCoFO4OY2Zs= Page 10/20 -Use or planned use to start a new course of hepatitis C therapy
    criteri di esclusione principali: • Pazienti che stanno assumendo altri farmaci sperimentali al momento dell’arruolamento o che li hanno assunti nei 30 giorni precedenti l’inizio dello studio o in un periodo di tempo pari a 5 emivite del farmaco, considerando il periodo piu' lungo • Pazienti che hanno iniziato o si prevede che inizieranno un nuovo ciclo di terapia per l’epatite C Per maggiori dettagli consultare i paragrafi 5.1 e 5.2 del protocollo originale.
    E.5 End points
    E.5.1Primary end point(s)
    To examine the proportion of patients who maintain HCV RNA viral load below lower limit of quantification (LOQ) at each scheduled time point.
    La variabile di efficacia primaria e' la proporzione dei pazienti che hanno mantenuto la carica virale (HCV RNA) sotto il limite di quantificazione (LOQ: Limit of Quantification) ad ogni valutazione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the 5 scheduled visits within three years.
    Durante le 5 visite programmate entro 3 anni
    E.5.2Secondary end point(s)
    -HCV RNA viral load -The proportion of patients who normalize alanine aminotransferase (ALT) -Liver fibrosis evaluations using Fibrotest and elastography, and to monitor for any changes over time using ultrasound of the liver and spleen -The proportion of relapsed patients -The proportion of re-infected patients -The safety assessment will be based on the analyses of adverse events, vital signs and laboratory evaluations
    - Carico virale del RNA di HCV - la percentuale di pazienti che normalizzano l'amminotransferasi alanina (ALT) - valutazioni di fibrosi del fegato facendo uso di Fibrotest e del elastografia e controllo nel tempo per qualsiasi cambiamenti facendo uso dell'ultrasuono del fegato e della milza - la percentuale di pazienti ricaduti - la percentuale di pazienti re-infettati - la valutazione di sicurezza sara' basata sulle analisi degli eventi avversi, delle funzioni vitali e delle valutazioni di laboratorio
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the 5 scheduled visits within three years.
    Durante le 5 visite programmate entro 3 anni
    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 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
    To assess the durability of sustained virologic response in alisporivir treated
    Valutazione della persistenza della risposta virologica continua nei pazienti trattati con alisporiv
    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 No
    E.8.1.2Open No
    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) 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 trial0
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA82
    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
    Argentina
    Australia
    Brazil
    Canada
    Egypt
    Hong Kong
    India
    Israel
    Korea, Republic of
    Mexico
    Philippines
    Russian Federation
    Taiwan
    Thailand
    Turkey
    United States
    Vietnam
    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
    LPLV : 19/JUN/2017
    LPLV : 19/06/2017
    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 months59
    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 months62
    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: 1300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 700
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-06-21. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state165
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1000
    F.4.2.2In the whole clinical trial 2000
    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. This study involves routine follow-up tests with blood samplings at each scheduled visit. No treatment is involved.
    Nessuno. E' uno studio di follow-up. Non c'e' nessun trattamento implicato.
    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 Decision2012-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-21
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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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