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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
Date last updated
23/09/2024

Titles & IDs
Public title
Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)
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)
Secondary ID [1] 0 0
2022-002268-53
Secondary ID [2] 0 0
219288
Universal Trial Number (UTN)
Trial acronym
B-Well 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 0 0
Hepatitis B, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants achieving functional cure (FC) with baseline HBsAg =3000 IU/mL
Timepoint [1] 0 0
Up to 72 weeks
Secondary outcome [1] 0 0
Number of participants achieving FC with baseline HBsAg =1000 IU/mL
Timepoint [1] 0 0
Up to 72 weeks
Secondary outcome [2] 0 0
Number of participants achieving sustained suppression of HBV DNA (<LLOQ) with baseline HBsAg =3000 IU/mL
Timepoint [2] 0 0
Up to 72 weeks
Secondary outcome [3] 0 0
Number of participants achieving sustained suppression of HBV DNA (<LLOQ) with baseline HBsAg =1000 IU/mL
Timepoint [3] 0 0
Up to 72 weeks

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/05/2026
Actual
Sample size
Target
Accrual to date
Final
871
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
GSK Investigational Site - Box Hill
Recruitment hospital [2] 0 0
GSK Investigational Site - Fitzroy
Recruitment hospital [3] 0 0
GSK Investigational Site - Herston
Recruitment hospital [4] 0 0
GSK Investigational Site - Westmead
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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United States of America
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California
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Colorado
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Virginia
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Washington
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Argentina
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Buenos Aires
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Santa Fe
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Botucatu
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Brazil
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Fortaleza
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Brazil
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Nova IguaCu
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Brazil
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Plovdiv
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Sliven
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Sofia
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Szeged
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SzEkesfehErvAr
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Nagpur
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Pune
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Raipur
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Cebu City
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Makati City
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Pasig City
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Silang
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Poland
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Gdansk
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Myslowice
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Zychlin
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Romania
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Bucharest
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Bucuresti
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Cluj Napoca
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Constanta
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Galati
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Romania
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Oradea
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Alcorcon Madrid
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Spain
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Badajoz
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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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Sabadell Barcelona
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Spain
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Sevilla
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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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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Thailand
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Chiangmai
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Turkey
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Ankara
Country [142] 0 0
Turkey
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Istanbul
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Turkey
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Izmir
Country [144] 0 0
United Kingdom
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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
Country [147] 0 0
United Kingdom
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Newcastle upon Tyne
Country [148] 0 0
United Kingdom
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Plymouth
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Vietnam
State/province [149] 0 0
Hanoi
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Vietnam
State/province [150] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05630820
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05630820