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    Summary
    EudraCT Number:2014-000453-37
    Sponsor's Protocol Code Number:3179/AO/14
    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:2014-09-03
    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 number2014-000453-37
    A.3Full title of the trial
    Sequential treatment with nucleotide analogue and peg-interferon in patients with HBV-related chronic hepatitis.
    TRATTAMENTO SEQUENZIALE CON ANALOGO NUCLEOTIDICO E PEG-INTERFERONE IN PAZIENTI CON EPATITE CRONICA HBV CORRELATA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with association of two drugs (Viread and Pegasys) in patients with hepatitis B.
    TRATTAMENTO CON ASSOCIAZIONE DI DUE FARMACI (VIREAD E PEGASYS) NEI PAZIENTI AFFETTI DA EPATITE B
    A.3.2Name or abbreviated title of the trial where available
    TRASANPIEC-HBV
    TRASANPIEC-HBV
    A.4.1Sponsor's protocol code number3179/AO/14
    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 Padova
    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 supportAzienda Ospedaliera di Padova
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliera di Padova
    B.5.2Functional name of contact pointU.O.C. Gastroenterologia
    B.5.3 Address:
    B.5.3.1Street AddressVia Giustiniani 2
    B.5.3.2Town/ cityPadova
    B.5.3.3Post code35128
    B.5.3.4CountryItaly
    B.5.4Telephone number+390498212890
    B.5.5Fax number+390498760820
    B.5.6E-mailepatitivirali.aopd@sanita.padova.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 Viread
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences
    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 nameViread
    D.3.4Pharmaceutical form 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 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
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Spa
    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 namePegasys
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 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 Yes
    D.3.11.13.1Other medicinal product typeCovalent conjugate of the protein interferon alfa-2a, produced by recombinant DNA technology.
    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
    Hepatitis B virus (HBV)
    EPATITE CRONICA HBV-CORRELATA
    E.1.1.1Medical condition in easily understood language
    Chronic liver disease caused by hepatitis B
    MALATTIA EPATICA CRONICA CAUSATA DAL VIRUS DELL’EPATITE B
    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
    Evaluate the effectiveness resulting from the addition of a treatment with Tenofovir before the start of therapy with peg-IFN-2a compared to treatment with peg-IFN-2a on the biochemical, virological and serological response in patients with chronic hepatitis HBeAg negative/positive .
    Valutare l’efficacia derivante dall’aggiunta di un trattamento con Tenofovir prima dell’inizio della terapia con Peg-interferone-2a rispetto al trattamento con Peg-interferone-2a sulla risposta biochimica, virologica e sierologica in pazienti con epatite cronica HBeAg negativa/positiva.
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with chronic hepatitis HBsAg positive, HBeAg negative HBV-DNA> 20,000 IU / mL in two successive determinations or chronic hepatitis HBsAg positive, HBeAg positive with HBV DNA> 20,000 IU / mL in two successive determinations;
    - for which the practitioner indicates a treatment with peg-interferon alfa-2a;
    - with transaminases > 2 times the normal range in two successive determinations;
    - anti-HDV, anti-HCV and anti-HIV negative;
    - of which there is liver biopsy performed within 24 months prior to the start of therapy or Fibroscan performed within 6 months, proving HBV-related chronic hepatitis;
    - observing absolute abstention from alcohol;
    - available to participate in the study (informed consensus).
    - Pazienti affetti da epatite cronica HBsAg positiva, HBeAg negativa con HBV-DNA >20.000 UI/mL in due successive determinazioni o affetti da epatite cronica HBsAg positiva, HBeAg positiva con HBV-DNA >20.000 UI/mL in due successive determinazioni;
    - per i quali il medico specialista ritiene indicato un trattamento con Peg-interferone alfa-2a;
    - con valori di transaminasi >2 volte la norma in due successive determinazioni;
    - anti-HDV, anti-HCV e anti-HIV negativi;
    - di cui è disponibile biopsia epatica eseguita entro i 24 mesi precedenti l’inizio della terapia o fibroscan eseguito entro i 6 mesi, comprovante epatite cronica HBV correlata;
    - che osservano astensione assoluta dalle bevande alcoliche;
    - disponibili alla partecipazione allo studio (consenso informato).
    E.4Principal exclusion criteria
    - Concomitant conditions that, in the opinion of the investigator, could compromise the patient's participation in the study or the results of the study, causing interference on the assessments provided by this protocol;
    - patients that are pregnant or breastfeeding;
    - people who are unable to understand and decide;
    - refusal to participation/withdrawal of consensus;
    - Hb <10 g/dl;
    - neutrophil count <1,500 cells/ml;
    - platelets <90,000 cells/ml;
    - treatment with antiviral therapy during the 12 months preceding the visit of enrollment in the study.
    - Concomitanza di condizioni che a giudizio dello sperimentatore possano compromettere la partecipazione del paziente allo studio o i risultati dello studio causando interferenze sulle valutazioni previste dal presente protocollo;
    - gravidanza o allattamento;
    - soggetti non in grado di intendere e decidere o con capacità offuscata;
    - rifiuto alla partecipazione/ritiro del consenso;
    - Hb<10 g/dl;
    - neutrofili < 1500 cellule/ml;
    - piastrine < 90000 cellule/ml;
    - trattamento con terapia antivirale nei 12 mesi che precedono la visita di arruolamento nello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of sustained virological response (HBV DNA levels <2000UI/mL)
    Tasso di risposta virologica sostenuta (livelli di HBV DNA < 2000UI/mL)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months from the end of treatment with peg-interferon alfa-2a
    6 mesi dalla fine del ciclo di trattamento con peg-interferone alfa-2a
    E.5.2Secondary end point(s)
    Rate of biochemical response (normalization of ALT: <40 U / L)
    Tasso di risposta biochimica (normalizzazione delle ALT: <40 U/L)
    E.5.2.1Timepoint(s) of evaluation of this end point
    6-12 months from the end of treatment with peg-interferon alfa-2a
    6-12 mesi dalla fine del ciclo di trattamento con peg-interferone alfa-2a
    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 No
    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) 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 Yes
    E.8.2.3.1Comparator description
    Pegasys
    Pegasys
    E.8.2.4Number of treatment arms in the trial2
    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 concerned7
    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 years3
    E.8.9.1In the Member State concerned months0
    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.1.1.1In 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: 80
    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 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 2014-09-03. Yes
    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 state80
    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 Decision2014-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
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