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    Summary
    EudraCT Number:2021-000554-26
    Sponsor's Protocol Code Number:206882
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-24
    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 ConcernedGreece - EOF
    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
    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.
    A.3.2Name or abbreviated title of the trial where available
    B-Sure
    A.4.1Sponsor's protocol code number206882
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04954859
    A.5.4Other Identifiers
    Name:INDNumber:122685
    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 & Development Limited
    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+44208990 9733
    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 nameBepirovirsen
    D.3.2Product code GSK3228836B (Free acid); GSK3228836A (Sodium salt)
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 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.3.9.3Other descriptive nameBepirovirsen sodium (United States Approved Name = USAN); ISIS 505358 (code used by Ionis Pharmaceuticals)
    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 number0
    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
    E.1.1.1Medical condition in easily understood language
    Hepatitis 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 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)
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participants who have previously received at least one dose of bepirovirsen AND
    a. Achieved SVR (defined as HBsAg <LLOQ and HBV DNA <LLOQ for 24 weeks after the actual end of treatment regimen in the absence of rescue medication) and who maintained SVR until the EoS visit in their previous treatment study (defined as complete responders to bepirovirsen from the parent study) OR
    b. Participants who have previously received at least 1 dose of bepirovirsen and demonstrated HBsAg reduction ≥1.0 log10 IU/mL from parent study Baseline with HBsAg levels <100 IU/mL and HBV DNA <LLOQ for 24 weeks after the actual end of treatment regimen, the absence of rescue medication) and maintained until their EoS visit in 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 protocol Section 10.1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    E.4Principal exclusion criteria
    1. Participants who have/or are currently participating in another non-GSK interventional clinical study exploring HBV treatment since completing their treatment with bepirovirsen.
    2. Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participant in this study.
    E.5 End points
    E.5.1Primary end point(s)
    • Time from achieving SVR in the previous bepirovirsen 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).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Defined in the primary endpoints
    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 bepirovirsen 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 bepirovirsen 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 bepirovirsen 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 bepirovirsen in the parent study and at the time of virologic breakthrough
    E.5.2.1Timepoint(s) of evaluation of this end point
    Defined in the secondary endpoints
    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 bepirovirsen studies designed to assess durability of efficacy of bepirovirsen: no further treatment with bepirovirsen will be administered in this study
    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
    Long term follow-up study to assess durability of efficacy of prior treatment with bepirovirsen
    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.8.3 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 EEA85
    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
    Canada
    China
    Hong Kong
    Japan
    Korea, Republic of
    Singapore
    South Africa
    Thailand
    United States
    France
    Poland
    Bulgaria
    Netherlands
    Romania
    Spain
    Germany
    Greece
    Italy
    Hungary
    Russian Federation
    United Kingdom
    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
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months5
    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 2023-01-24. 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    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
    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 Decision2023-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-21
    P. End of Trial
    P.End of Trial StatusOngoing
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