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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05630820
Registration number
NCT05630820
Ethics application status
Date submitted
21/11/2022
Date registered
30/11/2022
Titles & IDs
Public title
Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)
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Scientific title
Phase 3 Multicenter, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment With Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B Virus (B-Well 2)
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Secondary ID [1]
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0
2022-002268-53
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Secondary ID [2]
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219288
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Universal Trial Number (UTN)
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Trial acronym
B-Well 2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B
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0
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Hepatitis B, Chronic
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0
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Condition category
Condition code
Infection
0
0
0
0
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Other infectious diseases
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Oral and Gastrointestinal
0
0
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bepirovirsen
Other interventions - Placebo
Experimental: Bepirovirsen -
Placebo comparator: Placebo -
Treatment: Drugs: Bepirovirsen
Bepirovirsen will be administered.
Other interventions: Placebo
Matching placebo will be administered.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants achieving functional cure (FC) with baseline HBsAg =3000 IU/mL
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Assessment method [1]
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The number of participants who achieved FC after discontinuation of all chronic HBV treatment (bepirovirsen/placebo and NA) in the absence of rescue medication will be reported. The FC for HBV is defined as Sustained suppression (24 weeks or longer) of HBV DNA \<Lower limit of quantification (LLOQ) off all HBV treatment and HBsAg not detected with or without HBsAb after a finite duration of therapy.
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Timepoint [1]
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Up to 72 weeks
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Secondary outcome [1]
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Number of participants achieving FC with baseline HBsAg =1000 IU/mL
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Assessment method [1]
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The number of participants who achieved FC after discontinuation of all chronic HBV treatment (bepirovirsen/placebo and NA) in the absence of rescue medication will be reported. The FC for HBV is defined as Sustained suppression (24 weeks or longer) of HBV DNA (\<LLOQ) off all HBV treatment and HBsAb not detected with or without HBsAb after a finite duration of therapy.
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Timepoint [1]
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Up to 72 weeks
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Secondary outcome [2]
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Number of participants achieving sustained suppression of HBV DNA (<LLOQ) with baseline HBsAg =3000 IU/mL
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Assessment method [2]
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The number of participants who achieved sustained suppression of HBV DNA after discontinuation of all chronic HBV treatment (bepirovirsen/placebo and NA) in the absence of rescue medication will be reported.
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Timepoint [2]
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Up to 72 weeks
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Secondary outcome [3]
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Number of participants achieving sustained suppression of HBV DNA (<LLOQ) with baseline HBsAg =1000 IU/mL
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Assessment method [3]
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The number of participants who achieved sustained suppression of HBV DNA after discontinuation of all chronic HBV treatment (bepirovirsen/placebo and NA) in the absence of rescue medication will be reported.
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Timepoint [3]
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Up to 72 weeks
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Eligibility
Key inclusion criteria
* Participants who have documented chronic HBV infection =6 months prior to screening and currently receiving stable NA therapy defined as no changes to their NA regimen from at least 6 months prior to Screening and with no planned changes to the stable regimen over the duration of the study.
* Plasma or serum HBsAg concentration >100 IU/mL, but no greater than =3000 IU/mL.
* Plasma or serum HBV DNA concentration must be adequately suppressed, defined as plasma or serum HBV DNA <90 IU/mL.
* Alanine aminotransferase (ALT) =2 × upper limit of normal (ULN).
* Participants who are willing and able to cease their NA treatment in accordance with the protocol.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Clinically significant abnormalities, aside from chronic HBV infection in medical history (e.g., moderate severe liver disease other than chronic HBV, acute coronary syndrome within 6 months of screening, major surgery within 3 months of screening, significant/unstable cardiac disease, uncontrolled diabetes, bleeding diathesis or coagulopathy) or physical examination.
Co-infection with:
a) Current history of Hepatitis C infection or participants that have been cured for <12 months at the time of screening b) Human immunodeficiency virus (HIV), c) Hepatitis D virus.
* History of or suspected liver cirrhosis and/or evidence of cirrhosis.
* Diagnosed or suspected hepatocellular carcinoma.
* History of malignancy within the past 5 years except for specific cancers that are cured by surgical resection (e.g., skin cancer). Participants under evaluation for possible malignancy are not eligible.
* History of vasculitis or presence of symptoms and signs of potential vasculitis (e.g., vasculitic rash, skin ulceration, repeated blood detected in urine without identified cause) or history/presence of other diseases that may be associated with vasculitis condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex).
* History of extrahepatic disorders possibly related to HBV immune conditions (e.g., nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, uncontrolled hypertension).
* History of alcohol or drug abuse/dependence.
* Currently taking, or took within 3 months of screening, any immunosuppressing drugs (e.g., prednisone), other than a short course of therapy (=2 weeks) or topical/inhaled steroid use.
* Participants to whom immunosuppressive treatment, including therapeutic doses of steroids is contraindicated, should not be considered for enrolment in the study.
* Currently taking, or has taken within 12 months of Screening, any interferon containing therapy.
* Participants requiring anti coagulation therapies (e.g., warfarin, Factor Xa inhibitors) or anti-platelet agents (like clopidogrel or aspirin) unless treatment can safely be discontinued throughout duration of the study, by the discretion of the investigator. Occasional use is permitted.
* Prior treatment with any oligonucleotide or siRNA within 12 months prior to the first dosing day.
* Prior treatment with bepirovirsen.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/12/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
28/04/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
871
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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GSK Investigational Site - Box Hill
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GSK Investigational Site - Fitzroy
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GSK Investigational Site - Herston
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GSK Investigational Site - Westmead
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3128 - Box Hill
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3065 - Fitzroy
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Recruitment postcode(s) [3]
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4029 - Herston
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Recruitment postcode(s) [4]
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2145 - Westmead
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Recruitment outside Australia
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Alabama
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Romania
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Cluj Napoca
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Romania
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State/province [124]
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Constanta
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Country [125]
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Romania
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State/province [125]
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Galati
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Country [126]
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Romania
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Oradea
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Spain
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State/province [127]
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Alcorcon Madrid
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Spain
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Badajoz
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Country [129]
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Spain
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Granada
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Spain
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Madrid
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Spain
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State/province [131]
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Sabadell Barcelona
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Spain
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State/province [132]
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Sevilla
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Country [133]
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Spain
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Valencia
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Spain
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Valladolid
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Spain
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Zaragoza
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Country [136]
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Taiwan
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State/province [136]
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Kaohsiung
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Taiwan
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State/province [137]
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Taichung
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Taiwan
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Tainan
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Taiwan
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State/province [139]
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Taipei
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Thailand
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State/province [140]
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Chiangmai
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Country [141]
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Turkey
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State/province [141]
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Ankara
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Turkey
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Istanbul
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Turkey
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State/province [143]
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Izmir
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United Kingdom
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State/province [144]
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Liverpool
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United Kingdom
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London
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United Kingdom
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Middlesbrough
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
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State/province [148]
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Plymouth
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Country [149]
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Vietnam
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State/province [149]
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Hanoi
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Country [150]
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Vietnam
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State/province [150]
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Ho Chi Minh
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Ethics approval
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Summary
Brief summary
This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: a) Double-blind treatment (bepirovirsen or placebo) for 24 weeks. b) Nucleos(t)ide analogue (NA) treatment for 24 weeks. c) NA cessation stage OR Continue NA for 24 weeks. d) Durability of response and follow up for further 24 weeks for participants who stopped NA treatment at Week 48. The arms will be stratified based on HBsAg level (HBsAg greater than or equal to \[=\] 100 international unit per milliliter \[IU/mL\] to less than or equal \[=\]1000 IU/mL or greater than \[\>\] 1000 IU/mL to =3000 IU/mL) at screening. The total duration of the study, including screening (up to 60 days), the double-blind treatment stage (24 weeks), the On NA only stage (24 weeks), and the NA cessation and durability stages (48 weeks) is up to approximately 104 weeks at maximum for each participant.
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Trial website
https://clinicaltrials.gov/study/NCT05630820
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
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Available to whom?
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05630820