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    Summary
    EudraCT Number:2021-000554-26
    Sponsor's Protocol Code Number:206882
    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:2021-10-15
    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 number2021-000554-26
    A.3Full title of the trial
    A Prospective, Multi-Centre Study (B-Sure) to Evaluate Long-Term Durability of Sustained Virologic Response in Chronic Hepatitis B Participants With and Without Nucleos(t)ide Therapy Who Have Received and Responded to GSK3228836 in a Previous Treatment Study
    Studio prospettico, multicentrico (B-Sure) volto a valutare la durata a lungo termine della risposta virologica prolungata in soggetti affetti da epatite B cronica, con e senza terapia a base di nucleos(t)idici, che abbiano assunto e risposto a GSK3228836 quale trattamento di un precedente studio
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term follow-up study to evaluate durability of sustained virologic response in previous GSK3228836 study participants.
    Studio di follow-up a lungo termine per valutare la durata della risposta virologica sostenuta in precedenti partecipanti allo studio GSK3228836.
    A.3.2Name or abbreviated title of the trial where available
    B-Sure
    B-Sure
    A.4.1Sponsor's protocol code number206882
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04954859
    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 SponsorGLAXOSMITHKLINE RESEARCH AND DEVELOPMENT
    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 supportGlaxoSmithKline Research & Development Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClinical Trials Help Desk
    B.5.3 Address:
    B.5.3.1Street Address980 Great West Road
    B.5.3.2Town/ cityBrentford, Middlesex
    B.5.3.3Post codeTW8 9GS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442089909733
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameGSK3228836
    D.3.2Product code [GSK3228836B (Free acid); GSK3228836A (Sodium salt
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBepirovirsen
    D.3.9.1CAS number 1403787-62-1
    D.3.9.2Current sponsor codeGSK3228836
    D.3.9.4EV Substance CodeSUB208554
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Chronic Hepatitis B
    Epatite B cronica
    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 describe long-term durability of sustained virologic response (SVR) as measured by time to loss of SVR in the following two groups: • Treatment naïve participants who achieved a complete response.
    Participants who achieved a complete response in the parent study and either didn't meet the eligibility criteria or met the eligibility criteria and decided not to enrol will be included in the analysis.
    • NA controlled participants who achieved a complete response and discontinued NA treatment per protocol (Section 6.8.1 of the protocol)
    descrivere la durata a lungo termine della risposta virologica sostenuta (SVR) misurata in base al tempo della perdita di SVR nei seguenti due gruppi:
    - partecipanti naïve al trattamento che hanno ottenuto una risposta completa.
    I partecipanti che hanno ottenuto una risposta completa nello studio principale e non hanno soddisfatto i criteri di ammissibilità o hanno soddisfatto i criteri di ammissibilità e hanno deciso di non iscriversi saranno inclusi nell'analisi.
    - Partecipanti controllati con NA che hanno ottenuto una risposta completa e hanno interrotto il trattamento con NA secondo il protocollo (sezione 6.8.1 del protocollo)
    E.2.2Secondary objectives of the trial
    • Describe changes in disease after NA cessation as measured by time to HBsAg reversion, time to virologic relapse, time to clinical relapse and time to NA retreatment in NA controlled participants who achieved a complete response and discontinued NA treatment.
    • To describe long-term durability of sustained virologic response (SVR) as measured by time to loss of SVR in NA controlled participants who achieved a complete response and are continuing NA treatment.
    • Describe achieving delayed SVR in treatment naive participants who achieved a partial response, and describe time to loss of SVR in participants achieving delayed SVR.
    • Describe achieving delayed SVR in NA controlled participants who achieved a partial response, and describe time to loss of SVR in participants achieving delayed SVR.
    Please, refer to the study protocol for the complete list of secondary objectives.
    -descriv.le variazioni nella malattia dopo la fine del NA,misurate in base al tempo della reversione dell’HBsAg,della recidiva virologica,della recidiva clinica e del ritratt.del NA nei partecipanti controllati con NA che hanno avuto una risposta completa e interrotto il tratt.con NA.
    -descriv.la durata a lungo termine della risp.virologica sostenuta(SVR)misurata in base al tempo della perdita di SVR nei partecip.controllati con NA che hanno ottenuto una risp.completa e continuano il tratt.con NA.
    -descriv.il raggiungim.della SVR ritardata nei partecip.naïve al tratt.che hanno ottenuto una risposta parziale e descriv.il tempo della perdita di SVR nei partecipanti che hanno raggiunto la SVR ritardata.
    - descriv. il raggiungimento della SVR ritardata nei partecipanti controllati con NA che hanno ottenuto una risposta parziale e descriv.il tempo della perdita di SVR nei partecipanti che hanno raggiunto la SVR ritardata.
    Vedasi protocollo dello studio lista completa degli obiettivi 2ari.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participants who have previously received at least one dose of GSK3228836 AND
    a. Achieved SVR (defined as HBsAg <LLOQ and HBV DNA <LLOQ for 24 weeks after the end of previous investigational treatment [GSK3228836 and/or with or without pegylated interferon] in the absence of rescue medication) and who maintained SVR until the EoS visit in their previous treatment study (defined as complete responders to GSK3228836 from
    the parent study) OR
    b. Participants who have previously received at least one dose of GSK3228836 and demonstrated HBsAg reduction of =1.0 log10 IU/mL from their treatment study Baseline and also with HBsAg levels <100 IU/mL and HBV DNA <LLOQ for 24 weeks after the end of previous investigational treatment [GSK3228836] until the EoS visit in their previous treatment study in the absence of rescue medication (defined as partial responders to GSK3228836 from the parent study).
    2. Participants who enter the study on stable NA are willing and able to cease their NA treatment in accordance with the NA cessation schedule.
    3. Capable of giving signed informed consent as described in Section 10.1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    1. Partecipanti che hanno ricevuto in precedenza almeno una dose di GSK3228836 E
    a. Raggiunto SVR (definito come HBsAg <LLOQ e HBV DNA <LLOQ per 24 settimane dopo la fine del precedente trattamento sperimentale [GSK3228836 e/o con o senza interferone pegilato] in assenza di farmaci di salvataggio) e che hanno mantenuto SVR fino alla visita EoS nel loro precedente studio di trattamento (definito come rispondente completo a GSK3228836 da
    lo studio madre) OPPURE
    b. Partecipanti che hanno ricevuto in precedenza almeno una dose di GSK3228836 e hanno dimostrato una riduzione dell'HBsAg di =1,0 log10 IU/mL dal loro studio di trattamento basale e anche con livelli di HBsAg <100 IU/mL e HBV DNA <LLOQ per 24 settimane dopo la fine del precedente trattamento sperimentale [GSK3228836] fino alla visita EoS nel loro precedente studio di trattamento in assenza di farmaci di salvataggio (definiti come rispondenti parziali a GSK3228836 dallo studio principale).
    2. I partecipanti che entrano nello studio con NA stabile sono disposti e in grado di cessare il loro trattamento con NA in conformità con il programma di cessazione della NA.
    3. 3. In grado di dare il consenso informato firmato come descritto nella sezione 10.1 che include il rispetto dei requisiti e delle restrizioni elencate nel modulo di consenso informato (ICF) e in questo protocollo.
    E.4Principal exclusion criteria
    GSK interventional clinical study exploring HBV treatment since completing their
    treatment with GSK3228836.
    2. Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participant in this study.
    1. Partecipanti che hanno/stanno attualmente partecipando a un altro studio clinico non interventistico della
    GSK che esplora il trattamento dell'HBV dopo completato il loro trattamento con GSK3228836.
    2. 2. Qualsiasi condizione che, secondo l'opinione dello sperimentatore o del Medical Monitor, controindica la loro partecipazione a questo studio.
    E.5 End points
    E.5.1Primary end point(s)
    • Time from achieving SVR in the previous GSK3228836 treatment study to the loss of SVR (first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication).
    • Time from NA cessation to the loss of SVR (first occurrence of either HBsAg or HBV DNA reversion or first use of any rescue medication).
    • Tempo dal raggiungimento della SVR nel precedente studio di trattamento con GSK3228836 alla perdita di SVR (prima insorgenza di reversione di HBsAg o HBV DNA o primo uso di qualsiasi farmaco di soccorso).
    • Tempo dalla cessazione del NA alla perdita di SVR (prima insorgenza di reversione di HBsAg o HBV DNA o primo uso di qualsiasi farmaco di soccorso).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Defined in the primary endpoints
    Definito negli endpoint primari
    E.5.2Secondary end point(s)
    • Time from NA cessation to the first occurrence of HBsAg reversion or first use of any rescue medication
    • Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication
    • Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication
    • Time from NA cessation to NA retreatment
    • Time from achieving SVR in the previous GSK3228836 treatment study to the loss of SVR (first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication).
    • Time from end of treatment in the previous GSK3228836 treatment study to delayed SVR in the absence of rescue medication
    • In the subset of participants who go on to achieve a delayed SVR: Time to the loss of SVR from time of achieving delayed SVR
    • In NA controlled participants who are continuing NA treatment:
    - Time from end of treatment in the previous GSK3228836 treatment study to delayed SVR in the absence of any rescue medication
    - In the subset of participants who go on to achieve a delayed SVR: Time to the loss of SVR from time of achieving delayed SVR
    • In NA controlled participants who have discontinued NA treatment:
    - Time from NA cessation to delayed SVR, in the absence of NA retreatment.
    - In the subset of participants who go on to achieve a delayed SVR after NA cessation: Time to the loss of SVR from time of achieving SVR.
    • Time from NA cessation to HBsAg loss in the absence of any rescue medication
    • Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication
    • Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication
    • Time from NA cessation to the first occurrence of NA retreatment • Occurrence of anti-HBs (antibody to HBsAg)
    • Occurrence of anti-HBe (antibody to HBeAg)
    • Actual values and changes from Baseline (EoS visit in the parent study) at each study visit in HBsAg, HBV DNA, HBeAg, HBcrAg, HBV RNA levels.
    • Occurrence of mutations prior to treatment and post treatment
    • Tempo dalla cessazione del NA alla prima insorgenza di reversione di HBsAg o primo uso di qualsiasi farmaco di soccorso).
    • Tempo dalla cessazione del NA alla prima insorgenza di recidiva virologica o al primo utilizzo di qualsiasi farmaco di soccorso.
    • Tempo dalla cessazione del NA alla prima insorgenza di recidiva clinica o al primo utilizzo di qualsiasi farmaco di soccorso.
    • Tempo dalla cessazione del NA al ritrattamento con NA.
    • Tempo dal raggiungimento della SVR nel precedente studio di trattamento con GSK3228836 alla perdita di SVR (prima insorgenza di reversione di HBsAg o HBV DNA o primo uso di qualsiasi farmaco di soccorso).
    • Tempo dalla fine del trattamento nel precedente studio di trattamento con GSK2338836 alla SVR ritardata in assenza di farmaci di soccorso.
    • Nel sottogruppo di partecipanti che continuano a raggiungere una SVR ritardata: Tempo della perdita di SVR dal momento del raggiungimento di SVR ritardata.
    Nei partecipanti controllati con NA che continuano il trattamento con NA:
    • Tempo dalla fine del trattamento nel precedente studio di trattamento con GSK2338836 alla SVR ritardata in assenza di qualsiasi farmaco di soccorso.
    • Nel sottogruppo di partecipanti che continuano a raggiungere una SVR ritardata: Tempo della perdita di SVR dal momento del raggiungimento di SVR ritardata.
    Nei partecipanti controllati con NA che hanno interrotto il trattamento con NA:
    • Tempo dalla cessazione del NA alla SVR ritardata, in assenza di ritrattamento con NA.
    • Nel sottogruppo di partecipanti che continuano a raggiungere una SVR ritardata dopo la cessazione del NA: Tempo della perdita di SVR dal momento del raggiungimento della SVR.
    • Tempo dalla cessazione del NA alla perdita di HBsAg in assenza di qualsiasi farmaco di soccorso.
    • Tempo dalla cessazione del NA alla prima insorgenza di recidiva virologica o al primo utilizzo di qualsiasi farmaco di soccorso.
    • Tempo dalla cessazione del NA alla prima insorgenza di recidiva clinica o al primo utilizzo di qualsiasi farmaco di soccorso.
    • Tempo dalla cessazione del NA alla prima insorgenza di ritrattamento con NA.
    • Insorgenza di anti-HBs (anticorpo anti-HBsAg).
    • Insorgenza di anti-HBe (anticorpo anti-HBeAg).
    • Valori effettivi e variazioni rispetto al basale (visita EoS nello studio originario) a ogni visita dello studio nei livelli di HBsAg, HBV DNA, HBeAg, HBcrAg, HBV RNA.
    • Insorgenza di mutazioni prima di GSK3228836 nello studio originario e al momento del breakthrough virologico.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Defined in the secondary endpoints
    Definito negli endpoint secondari
    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 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 Yes
    E.6.13.1Other scope of the trial description
    This is a rollover study from prior GSK3228836 studies designed to assess durability of efficacy of GSK3228836: no further treatment with GSK3228836 will be administered in this study
    Questo è uno studio di rollover da studi precedenti su GSK3228836 progettato per valutare la durata dell'efficacia di GSK3228836: nessun ulteriore trattamento con GSK3228836 sarà somministrato in questo studio
    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 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 Yes
    E.8.1.7.1Other trial design description
    Studio di follow-up a lungo termine per valutare la durata dell'efficacia del trattamento con GSK322
    Long term follow-up study to assess durability of efficacy of prior treatment with GSK3228836
    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.8.2.4Number of treatment arms in the trial1
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA74
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    China
    Hong Kong
    Japan
    Korea, Republic of
    Malaysia
    Philippines
    Russian Federation
    Singapore
    South Africa
    Taiwan
    Thailand
    United States
    Bulgaria
    France
    Germany
    Italy
    Netherlands
    Poland
    Romania
    Spain
    United Kingdom
    Argentina
    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 years7
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months5
    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.1.1.1In 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: 338
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 112
    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 2021-10-15. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 76
    F.4.2.2In the whole clinical trial 450
    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 Decision2021-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-15
    P. End of Trial
    P.End of Trial StatusOngoing
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