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    Summary
    EudraCT Number:2014-004939-39
    Sponsor's Protocol Code Number:GS-EU-174-1403
    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:2021-01-19
    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 number2014-004939-39
    A.3Full title of the trial
    Pharmacoepidemiology study to define the long-term safety profile of tenofovir disoproxil fumarate (Tenofovir DF, Viread¿) and describe the management of Tenofovir DF-associated renal and bone toxicity in Chronic Hepatitis B (CHB)-infected adolescents aged 12 to <18 years in Europe
    Studio farmacoepidemiologico per definire il profilo di sicurezza a lungo termine di tenofovir disoproxil fumarato (Tenofovir DF, Viread¿) e descrivere la gestione di tossicit¿ renale e ossea Tenofovir DF-associata in adolescenti dai 12 ai <18 anni affetti da epatite cronica B (CHB) in Europa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacoepidemiology study to define the long-term safety profile of tenofovir disoproxil fumarate (Tenofovir DF, Viread¿) and describe the management of Tenofovir DF-associated renal and bone toxicity in Chronic Hepatitis B (CHB)-infected adolescents aged 12 to <18 years in Europe
    Studio farmacoepidemiologico per definire il profilo di sicurezza a lungo termine di tenofovir disoproxil fumarato (Tenofovir DF, Viread¿) e descrivere la gestione di tossicit¿ renale e ossea Tenofovir DF-associata in adolescenti dai 12 ai <18 anni affetti da epatite cronica B (CHB) in Europa
    A.3.2Name or abbreviated title of the trial where available
    Not applicable
    Non applicabile
    A.4.1Sponsor's protocol code numberGS-EU-174-1403
    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 SponsorGILEAD SCIENCES INCORPORATED
    B.1.3.4CountryUnited Kingdom
    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 supportGilead Sciences Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressGranta Park
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 01223 897284
    B.5.5Fax number+44 01223 897284
    B.5.6E-mailclinical.trials@gilead.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 Yes
    D.2.1.1.1Trade name VIREAD
    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.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNTENOFOVIR DISOPROXIL FUMARATO
    D.3.9.1CAS number 202138-50-9
    D.3.9.2Current sponsor codeTENOFOVIR DISOPROXIL FUMARATO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Long term infection with the hepatitis B virus
    Infezione a lungo termine con virus dell'epatite B
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10008910
    E.1.2Term Chronic hepatitis B
    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 long term (i.e., 96 weeks of follow up) bone safety profile of open-label Tenofovir DF treatment in CHB infected adolescents.
    This includes prospectively evaluating and comparing the bone mineral density (BMD) change between CHB- infected adolescents 12 to < 18
    years of age treated with Tenofovir DF in European treatment centers who are assigned to one of two schedules for renal and bone laboratory monitoring and BMD measurement. Primary study outcome will be the percent changes in BMD from Baseline through study Week 96.
    Caratterizzare il profilo di sicurezza osseo a lungo termine (96 settimane di follow up) del trattamento con Tenofovir DF in aperto in adolescenti con CHB. Ci¿ comporta la valutazione e il confronto prospettici della variazione della densit¿ minerale ossea (DMO) tra gli adolescenti di et¿ compresa tra 12 e <18 anni con epatite cronica B (CHB) trattati con Tenofovir DF presso centri di trattamento europei e assegnati a uno di due programmi di monitoraggio con esami di laboratorio per la funzionalit¿ renale e ossea e misurazione della DMO. L'esito primario dello studio sar¿ la variazione percentuale della DMO dal valore basale alla Settimana 96 dello studio.
    E.2.2Secondary objectives of the trial
    ¿To document all serious adverse drug reactions (SADR) and all renal and bone-related adverse events (AEs), including renal and bone
    laboratory abnormalities
    ¿To determine the time to diagnosis of renal and bone AEs and document the resulting patient management and outcome(s)
    ¿To assess the clinical management and outcomes of renal and bone related = Grade 3 laboratory markers and clinical SAEs
    ¿To assess the efficacy and tolerability of Tenofovir DF in adolescents with CHB infection
    ¿ Documentare tutte le reazioni avverse da farmaci serie (SADR, serious adverse drug reactions) e tutti gli eventi avversi (EA) relativi alla funzionalit¿ renale e alle ossa comprese le anomalie di laboratorio renali e ossee.
    ¿ Determinare il tempo alla diagnosi degli EA renali e ossei e documentare la conseguente gestione del paziente e gli esiti.
    ¿ Valutare la gestione clinica e gli esiti dei SAE clinici e dei marcatori di laboratorio di grado =3 relativi alla funzionalit¿ renale e ossea.
    ¿ Valutare l'efficacia e la tollerabilit¿ di Tenofovir DF in adolescenti con infezione CHB.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) 12 to <16 years of age
    2) Documented chronic HBV infection (e.g. positive serum HBsAg >= 6 months)
    3) Weight >= 35 kg
    4) Able to swallow oral tablets
    5) Subjects must be naïve to Tenofovir DF, but could have received interferon or any oral anti-HBV nucleoside/nucleotide therapy
    1) 12 a <16 anni di età
    2) documentata infezione cronica da HBV (ad es. HBsAg sierico positivo > = 6 mesi)
    3) Peso> = 35 kg
    4) capacità di deglutire le compresse per via orale
    5) I soggetti devono essere liberi daTenofovir DF, ma potrebbero aver ricevuto interferone o qualsiasi terapia orale anti-HBV con nucleoside/nucleotide
    E.4Principal exclusion criteria
    1)Prior Tenofovir DF therapy; subjects may have received prior interferon or oral anti HBV nucleoside/nucleotide therapy (subjects experienced on interferon must have discontinued therapy for a minimum of six months; treatment-experienced subjects receiving oral anti-HBV nucleoside/nucleotide treatment at screening should continue their current treatment regimen until Tenofovir DF is initiated (i.e., to prevent ALT flare))
    2)Sexually-active males or females of reproductive potential who are not willing to use an effective method of contraception during the study.
    3)Females who are pregnant or breastfeeding, or females who wish to become pregnant during the course of the study.
    4)Known hypersensitivity to Tenofovir DF, the metabolites or formulation excipients
    5)Any condition (including alcohol or substance abuse) or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with treatment
    requirements
    1) Precedente terapia con Tenofovir DF;soggetti possono aver ricevuto prima interferone o terapia orale anti-HBV con nucleoside/nucleotide(soggetti che hanno assunto interferone devono avere interrotto la terapia per minimo 6 mesi;soggetti già trattati che ricevono terapia orale anti-HBV nucleoside/nucleotide allo screening devono continuare il loro regime di trattamento corrente fino a che Tenofovir DF verrà iniziato(ad es per prevenire sbalzo ALT))
    2) i soggetti maschi sessualmente attivi o femmine in età fertile che non sono disposti a utilizzare un metodo contraccettivo efficace durante lo studio.
    3) Le donne in gravidanza o allattamento, o donne che vogliono intraprendere una gravidanza durante il corso dello studio.
    4) Ipersensibilità nota a Tenofovir DF, metaboliti o
    formulazione di eccipienti
    5) Qualsiasi condizione (incluso l'alcool o abuso di sostanze) o precedente terapia che, a giudizio dello sperimentatore, potrebbe rendere il soggetto
    inadatto per lo studio o non in grado di rispettare il trattamento
    E.5 End points
    E.5.1Primary end point(s)
    The identification of bone AEs occurring in subjects taking Tenofovir DF between Baseline and Week 96 of treatment, including the identification of =4% percent reduction in BMD within subjects and between monitoring groups from Baseline.
    L'identificazione di EAs ossei che si verificano in soggetti che assumono Tenofovir DF tra il basale e la settimana 96 di trattamento, inclusa l'identificazione di una riduzione della DMO =4% tra soggetti gruppi di controllo dal basale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Between baseline to week 96
    tra il basale e la settimana 96
    E.5.2Secondary end point(s)
    ¿Documentation of renal or bone AEs and outcomes among subjects receiving Tenofovir DF, including rates of medication withdrawal or drug discontinuation
    ¿Subjects' cumulative exposure time on Tenofovir DF at the time renal or bone AEs are detected up to and including Week 96 or to study discontinuation (subjects without renal or bone AEs will contribute
    cumulative exposure time on Tenofovir DF from Baseline to Week 96 or to study discontinuation). The cumulative time to renal or bone AEs will
    be expressed as incident rates.
    ¿Documentation of the medical management and classification of detected renal or bone laboratory abnormalities
    ¿Analysis of subjects' virological and immunological status from Baseline to Week 96 under real world treatment practices
    ¿ Documentazione di EAs e degli esiti renali o ossei avvenuti in soggetti trattati con Tenofovir DF, inclusi i tassi di astinenza farmaci o sospensione del farmaco
    ¿ tempo di esposizione cumulativa dei soggetti a tenofovir DF nel momento dell'identificazione dei EAs renali e ossei fino alla settimana 96 o per studiare la sospensione (soggetti senza EAs renali o ossei contribuiranno al tempo di esposizione cumulativa a Tenofovir DF dal basale alla settimana 96 o per studiare la sospensione). Il tempo cumulativo di EAs renali o ossei verr¿ espresso come i tassi di incidenza.
    ¿ Documentazione della gestione medica e classificazione delle rilevato anomalie di laboratorio renali o ossee
    ¿ Analisi dello stato virologico e immunologico dei soggetti dal basale alla settimana 96 sottoposti a pratiche di trattamento reali
    E.5.2.1Timepoint(s) of evaluation of this end point
    Between baseline to week 96
    tra il basale e la settimana 96
    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 Yes
    E.6.13.1Other scope of the trial description
    Pharmacoepidemiology
    Farmacoepidemiologia
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Monitoraggio standard versus un monitoraggio approfondito
    Standard monitoring versus enhanced monitoring
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 Information not present in EudraCT
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 100
    F.1.2Adults (18-64 years) No
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    Tenofovir disoproxil fumarate is commercially available in the EU.
    Tenofovir disoproxil fumarato ¿ disponibile in commercio in Unione Europea
    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 Decision2015-11-16
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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