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    The EU Clinical Trials Register currently displays   35891   clinical trials with a EudraCT protocol, of which   5892   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-000815-15
    Sponsor's Protocol Code Number:HLS14/01
    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:2014-12-22
    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 number2014-000815-15
    A.3Full title of the trial
    Effects of a late add-on therapy of pegylated interferon (peg-IFNA) to ongoing nucleos(t)ide
    analogs (NUCs) in patients with chronic hepatitis B (CHB).
    Studio randomizzato e controllato sugli effetti clinici e immunologici di una terapia di associazione sequenziale con interferone peghilato-α-2a in pazienti con epatite cronica B in terapia efficace di lungo termine con analoghi nucleos(t)idici.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    add-on therapy of HBV chronic infection
    Terapia di associazione sequenziale della epatite B cronica
    A.4.1Sponsor's protocol code numberHLS14/01
    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, Polo Universitario Luigi Sacco, Milano
    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 supportUniversità degli Studi di Milano
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliera, Polo Universitario Luigi Sacco, Milano
    B.5.2Functional name of contact pointIII Division of Infectious Diseases
    B.5.3 Address:
    B.5.3.1Street AddressVia GB Grassi 74
    B.5.3.2Town/ cityMilan
    B.5.3.3Post code20157
    B.5.3.4CountryItaly
    B.5.6E-maillaura.milazzo@unimi.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 Pegasys
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Spa/ Registration limited UK
    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 namepegylated interferon alpha 2a
    D.3.4Pharmaceutical form Suspension for injection in pre-filled pen
    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 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 B
    Epatite B cronica
    E.1.1.1Medical condition in easily understood language
    Chronic Hepatitis B
    epatite B cronica
    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 whether add-on of peg-IFN-a to an ongoing effective nucleos(t)ide therapy achieve higher rates of seroconversion in CHB patients.
    Determinare se l’aggiunta di Peg-IFN-α-2a ad un trattamento efficace di lunga durate con analoghi nucleos(t)idici determini un maggior tasso di sieroconversione di HBeAg e HBsAg in soggetti con CHB, rispetto a coloro che proseguono con la monoterapia con NUCs.
    E.2.2Secondary objectives of the trial
    To investigate the the immunomodulatory action of IFNα, particularly on the host innate response through the analysis of the mechanisms involved in the restoration of NK cell effector functions in the “add-on” strategy described above.
    Studiare l’effetto immunomodulante della strategia “add-on” con Peg-IFN sulla risposta innata (NK, NKT) e specifica (T CD8+). Considerando i differenti effetti immunologici dei NUCs e dell’IFNα è atteso un cambiamento dei parametri relativi alla conta e funzione delle cellule NK, NKT, e T CD8+.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    age 18-65 years
    HBsAg positivity
    treatment with NUCs for at least 2 years;
    compensated liver disease;
    Hb > 12 g/dl
    WBC > 3000/mm3
    PLT >100000
    ANA, AMA, ASMA, LKM-Ab negativity
    HCV-Ab and HIV-Ab negative;
    Signed informed consent
    età compresa tra i 18 e i 65 anni
    HBsAg positività
    Trattamento da almeno due anni con NUCs
    malattia epatica compensata che soddisfi i seguenti criteri:
    emoglobina > 12 g/dl
    WBC > 3000/mm3
    Piastrine >100000
    negatività degli autoanticorpi (ANA, AMA, ASMA, LKM, anticorpi antitireoglobulina e antimicrosomi tiroidei)
    HCV-Ab e HIV-Ab negativi
    In entrambi i sessi l’impegno a non procreare per tutta la durata del trattamento e per 6 mesi dopo la sospensione.
    Sottoscrizione del consenso informato scritto
    E.4Principal exclusion criteria
    HCV or HIV coinfection;
    Pregnancy:
    Other liver diseases besides chronic hepatitis B fuori dell’epatite B;
    decompensated liver disease;
    Autoimmunity;
    Major depression
    hypersensitivity to Pegylated interferon
    Uncontrolled pilepsy
    coinfezione con HCV o HIV
    Gravidanza e allattamento
    altre cause di malattia epatica al di fuori dell’epatite B (abuso alcolico, epatiti autoimmuni, emocromatosi, epatopatia da farmaci)
    malattia epatica con segni di scompenso ascitico, biochimico o con segni di encefalopatia.
    Patologie immunomediate (LES, anemia emolitica autoimmune, psoriasi)
    Depressione maggiore con idee suicide
    Ipersensibilità a interferone
    Convulsioni non controllate
    E.5 End points
    E.5.1Primary end point(s)
    Loss of HBsAg and/or HBeAg
    Perdita di HBsAg o di HBeAg
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline-week12-week24-week48
    Al tempo basale, a 12-24 e 48 settimane di tratatmento.
    E.5.2Secondary end point(s)
    Sustained virological response or therapy suspension at the end of 48 weeks of treatment.
    Raggiungimento di una risposta virologica sostenuta (sieroconversione ad anti-HBeAg o anti-HBsAg) o sospensione della terapia con Peg-IFN-α alla fine delle 48 settimane previste.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12-24-48-weeks
    12-24-48 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 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 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 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.8.5The 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 years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 40
    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 state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 40
    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 Decision2015-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-22
    P. End of Trial
    P.End of Trial StatusOngoing
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