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Chronic Hepatitis BPhase 3NCT05630807

Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)

A Phase 3 study testing Bepirovirsen in people with Chronic Hepatitis B and Hepatitis B, Chronic, run by GlaxoSmithKline at 177 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Hepatitis B, Hepatitis B, Chronic
What is being tested?
Bepirovirsen
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
981 participants
Where
177 sitesin 26 countries
Study dates
7 Dec 2022to 15 Apr 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
  • 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.
Show all 15Show fewer
  • 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) current or history of an autoimmune condition 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.

Trial locations and contacts

177 sites in 26 countries.

177 sites in 26 countries

China24 sites

  • GSK Investigational Site

    Beijing, 100015

  • GSK Investigational Site

    Beijing, 100050

  • GSK Investigational Site

    Beijing

  • GSK Investigational Site

    Changchun, 130021

  • GSK Investigational Site

    Chengdu

  • GSK Investigational Site

    Chongqing, 400042

  • GSK Investigational Site

    Fuzhou, 350025

  • GSK Investigational Site

    Guangzhou, 510060

  • GSK Investigational Site

    Guangzhou, 510515

  • GSK Investigational Site

    Guangzhou, 510630

  • GSK Investigational Site

    Hangzhou, 310003

  • GSK Investigational Site

    Hangzhou, 310022

  • GSK Investigational Site

    Kunming, 650021

  • GSK Investigational Site

    Nanjing, 210008

  • GSK Investigational Site

    Shanghai, 200025

  • GSK Investigational Site

    Shanghai, 200040

  • GSK Investigational Site

    Shanghai, 200083

  • GSK Investigational Site

    Shenyang, 110022

  • GSK Investigational Site

    Shenzhen, 518112

  • GSK Investigational Site

    Ürümqi, 830054

  • GSK Investigational Site

    Wuhan, 430022

  • GSK Investigational Site

    Xi'an, 710061

  • GSK Investigational Site

    Zhengzhou, 450000

  • GSK Investigational Site

    Zhenjiang

Other trials in China

India15 sites

  • GSK Investigational Site

    Belagavi, 590010

  • GSK Investigational Site

    Chandigarh, 160012

  • GSK Investigational Site

    Chennai, 600113

  • GSK Investigational Site

    Coimbatore, 641005

  • GSK Investigational Site

    Guhawati, 781006

  • GSK Investigational Site

    Hyderabad, 500033

  • GSK Investigational Site

    HyderabadTelangana, 500048

  • GSK Investigational Site

    Jaipur, 302001

  • GSK Investigational Site

    Ludhiana, 141001

  • GSK Investigational Site

    Manipal, 576104

  • GSK Investigational Site

    Mumbai, 400 008

  • GSK Investigational Site

    Mumbai, 400012

  • GSK Investigational Site

    Mumbai, 400026

  • GSK Investigational Site

    Pune, 411001

  • GSK Investigational Site

    Surat, 395002

Other trials in India

Japan15 sites

  • GSK Investigational Site

    Chiba, 272-8516

  • GSK Investigational Site

    Ehime, 790-8524

  • GSK Investigational Site

    Fukuoka, 820-8505

  • GSK Investigational Site

    Fukuoka, 839-0863

  • GSK Investigational Site

    Gifu, 500-8717

  • GSK Investigational Site

    Gifu, 503-8502

  • GSK Investigational Site

    Hiroshima, 734-8551

  • GSK Investigational Site

    Hiroshima, 737-0023

  • GSK Investigational Site

    Hokkaido, 053-8506

  • GSK Investigational Site

    Hyōgo, 660-8550

  • GSK Investigational Site

    Kumamoto, 862-8655

  • GSK Investigational Site

    Miyagi, 980-8574

  • GSK Investigational Site

    Tokyo, 113-8519

  • GSK Investigational Site

    Tokyo, 173-8610

  • GSK Investigational Site

    Tokyo, 180-8610

Other trials in Japan

United States12 sites

  • GSK Investigational Site

    Baltimore, Maryland, 21287

  • GSK Investigational Site

    Chandler, Arizona, 85224

  • GSK Investigational Site

    Davis, California, 95817

  • GSK Investigational Site

    Detroit, Michigan, 48377

  • GSK Investigational Site

    Iowa City, Iowa, 52242

  • GSK Investigational Site

    Littleton, Colorado, 80120

  • GSK Investigational Site

    Los Angeles, California, 90027

  • GSK Investigational Site

    Miami, Florida, 33134

  • GSK Investigational Site

    Palo Alto, California, 94304

  • GSK Investigational Site

    Richmond, Virginia, 23249

  • GSK Investigational Site

    Richmond, Virginia, 23298

  • GSK Investigational Site

    San Jose, California, 95116

Other trials in United States

Spain10 sites

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    León, 24080

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Salamanca, 37007

  • GSK Investigational Site

    Santander, 39008

  • GSK Investigational Site

    Valencia, 46014

  • GSK Investigational Site

    Valladolid, 47003

  • GSK Investigational Site

    Vigo, 36002

Other trials in Spain

Brazil9 sites

  • GSK Investigational Site

    Aracaju, 49060-010

  • GSK Investigational Site

    Campinas, 13034-685

  • GSK Investigational Site

    Curitiba, 80810-050

  • GSK Investigational Site

    Manaus, 69040-000

  • GSK Investigational Site

    Porto Alegre, 90035003

  • GSK Investigational Site

    Santa Maria, 97105-900

  • GSK Investigational Site

    São Paulo, 05403-000

  • GSK Investigational Site

    São Paulo, 08270-070

  • GSK Investigational Site

    Vila Mariana, 04121-000

Other trials in Brazil

France9 sites

  • GSK Investigational Site

    Clermont-Ferrand, 63003

  • GSK Investigational Site

    Clichy, 92118

  • GSK Investigational Site

    Dijon, 21079

  • GSK Investigational Site

    Lille, 59037

  • GSK Investigational Site

    Pessac, 33604

  • GSK Investigational Site

    Poitiers, 86021

  • GSK Investigational Site

    Rennes, 35033

  • GSK Investigational Site

    Strasbourg, 67091

  • GSK Investigational Site

    Toulouse, 31059

Other trials in France

Canada8 sites

  • GSK Investigational Site

    Montreal, Quebec, H2X 0A9

  • GSK Investigational Site

    Montreal, Quebec, H4A 3J1

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6

  • GSK Investigational Site

    Québec, Quebec, G1V 4G2

  • GSK Investigational Site

    Saint-Jérôme, Quebec, J7Z 2V4

  • GSK Investigational Site

    Toronto, Ontario, M5G 2C4

  • GSK Investigational Site

    Vancouver, British Columbia, V6Z 2K5

  • GSK Investigational Site

    Victoria, British Columbia, V8V 3M9

Other trials in Canada

Germany8 sites

  • GSK Investigational Site

    Berlin, 10243

  • GSK Investigational Site

    Berlin, 10439

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Berlin, 12163

  • GSK Investigational Site

    Bochum, 44787

  • GSK Investigational Site

    Cologne, 50668

  • GSK Investigational Site

    Düsseldorf, 40225

  • GSK Investigational Site

    München, 80336

Other trials in Germany

South Korea8 sites

  • GSK Investigational Site

    Ansan, 15355

  • GSK Investigational Site

    Busan, 47392

  • GSK Investigational Site

    Daegu, 41944

  • GSK Investigational Site

    Daegu, 42601

  • GSK Investigational Site

    Seoul, 03080

  • GSK Investigational Site

    Seoul, 06351

  • GSK Investigational Site

    Seoul, 07061

  • GSK Investigational Site

    Seoul, 08308

Other trials in South Korea

Argentina6 sites

  • GSK Investigational Site

    Buenos Aires, 1061

  • GSK Investigational Site

    Buenos Aires, C1061AAS

  • GSK Investigational Site

    Buenos Aires, C1125ABE

  • GSK Investigational Site

    Capital Federal, C1181ACI

  • GSK Investigational Site

    Derqui Pilar, B1629AHJ

  • GSK Investigational Site

    Rosario, S2002KDT

Other trials in Argentina

Italy6 sites

  • GSK Investigational Site

    Brescia, 25123

  • GSK Investigational Site

    Foggia, 71100

  • GSK Investigational Site

    Messina, 98124

  • GSK Investigational Site

    Milan, 20122

  • GSK Investigational Site

    Milan, 20162

  • GSK Investigational Site

    Modena, 40126

Other trials in Italy

Malaysia6 sites

  • GSK Investigational Site

    George Town

  • GSK Investigational Site

    Johor Bahru, 80100

  • GSK Investigational Site

    Kota Bharu Kelantan

  • GSK Investigational Site

    Kota Kinabalu

  • GSK Investigational Site

    Kuala Lumpur

  • GSK Investigational Site

    Kuantan

Other trials in Malaysia

Romania6 sites

  • GSK Investigational Site

    Bucharest, 021105

  • GSK Investigational Site

    Bucharest, 20125

  • GSK Investigational Site

    Cluj-Napoca, 400162

  • GSK Investigational Site

    Iași, 700116

  • GSK Investigational Site

    Suceava, 720224

  • GSK Investigational Site

    Timișoara, 300001

Other trials in Romania

Taiwan5 sites

  • GSK Investigational Site

    Kaohsiung City, 807

  • GSK Investigational Site

    Kaohsiung City, 833

  • GSK Investigational Site

    Taichung, 40705

  • GSK Investigational Site

    Taipei, 104

  • GSK Investigational Site

    Tau-Yuan, 333

Other trials in Taiwan

United Kingdom5 sites

  • GSK Investigational Site

    Birmingham, B15 2TH

  • GSK Investigational Site

    Edinburgh, EH4 2XU

  • GSK Investigational Site

    Leeds West Yorkshire, LS9 7TF

  • GSK Investigational Site

    London, SE5 9RS

  • GSK Investigational Site

    London, SW17 0QT

Other trials in United Kingdom

Bulgaria4 sites

  • GSK Investigational Site

    Sofia, 1431

  • GSK Investigational Site

    Sofia, 1606

  • GSK Investigational Site

    Sofia

  • GSK Investigational Site

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Greece4 sites

  • GSK Investigational Site

    Athens, 10676

  • GSK Investigational Site

    Athens, 11527

  • GSK Investigational Site

    Periohi Dragana Alexand, 68100

  • GSK Investigational Site

    Rio Patras, 26504

Other trials in Greece

Hungary4 sites

  • GSK Investigational Site

    Budapest, 1097

  • GSK Investigational Site

    Eger, 3300

  • GSK Investigational Site

    Gyula, 5700

  • GSK Investigational Site

    Miskolc, 3530

Other trials in Hungary

Hong Kong3 sites

  • GSK Investigational Site

    Kowloon

  • GSK Investigational Site

    Pokfulam

  • GSK Investigational Site

    Shatin

Other trials in Hong Kong

Poland3 sites

  • GSK Investigational Site

    Bytom, 41-902

  • GSK Investigational Site

    Krakow, 31-202

  • GSK Investigational Site

    Łańcut, 37-100

Other trials in Poland

Mexico2 sites

  • GSK Investigational Site

    Guadalajara, 44160

  • GSK Investigational Site

    Oaxaca City, 68000

Other trials in Mexico

Singapore2 sites

  • GSK Investigational Site

    Singapore, 119074

  • GSK Investigational Site

    Singapore, 169608

Other trials in Singapore

Panama1 site

  • GSK Investigational Site

    Panama City, 07206

Other trials in Panama

Thailand1 site

  • GSK Investigational Site

    Bangkok, 10330

Other trials in Thailand

Turkey (Türkiye)1 site

  • GSK Investigational Site

    Ankara, 06230

Other trials in Turkey (Türkiye)

About this study

Official 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 1)

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.

Being tested
Bepirovirsen, Placebo
Keywords
Hepatitis, Chronic Hepatitis, Chronic Hepatitis B, Hepatitis B Virus, hepatitis B virus e-antigen, Bepirovirsen, Nucleos(t)ide analogue, Antisense Oligonucleotide, 202009, 219288
Medical subject headings
Hepatitis B, Chronic, Hepatitis, Hepatitis, Chronic, Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BepirovirsenDrug

    Bepirovirsen will be administered.

  • PlaceboOther

    Matching placebo will be administered.

Study groups in NCT05630807
Study groupRoleWhat they receive
BepirovirsenExperimentalNot described
Receives: Drug: Bepirovirsen
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants achieving functional cure (FC) with baseline HBsAg ≤3000 IU/mL

    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.

    Measured: Up to 72 weeks

Secondary outcomes (3)

  1. Number of participants achieving FC with baseline HBsAg ≤1000 IU/mL

    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) and HBsAg not detected with or without HBsAb after a finite duration of therapy.

    Measured: Up to 72 weeks

  2. Number of participants achieving sustained suppression of HBV DNA (<LLOQ) with baseline HBsAg ≤3000 IU/mL

    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.

    Measured: Up to 72 weeks

  3. Number of participants achieving sustained suppression of HBV DNA (<LLOQ) with baseline HBsAg ≤1000 IU/mL

    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.

    Measured: Up to 72 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2022
  2. Study start7 Dec 2022
  3. Primary completion11 Nov 2025
  4. Study completion15 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a multicenter, randomized, double-blind, placebo-controlled study.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
981 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05630807
Sponsor's protocol ID
202009
Other IDs
2021-005139-22
Status last verified
Jul 2026
First submitted
21 Nov 2022
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/

Publications

  • Hou J, Lim SG, Buti M, Yuen MF, Gane E, Lampertico P, Terrault N, Nguyen H, Yim HJ, Xie Q, Lin J, Qiu Y, Jeng WJ, Heo J, Peng CY, Chen CH, Chuang WL, Xie Y, Hlebowicz M, Idriz N, Mehta R, Agarwal K, Gomes da Silva MM, Franca A, Cernat R, Leerapun A, Coffin CS, Gadano A, Andreone P, Fujiyama S, Sevastianos V, Suzuki Y, Ratziu V, Riachi G, Stocker H, Lim TH, Asselah T, Tanaka Y, Holmes J, Liang X, Cremer J, Lukic T, Plein H, Quinn G, Tao Y, Paff M, Theodore D, Elston R; B-Well Study Group. Phase 3 Results of Bepirovirsen Treatment for Chronic Hepatitis B Virus Infection. N Engl J Med. 2026 Jun 25;394(24):2395-2406. doi: 10.1056/NEJMoa2515131. Epub 2026 May 28.

    PubMed 42206582

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bepirovirsen in people with Chronic Hepatitis B and Hepatitis B, Chronic, run by GlaxoSmithKline at 177 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 177 sites in China, India, Japan, United States, Spain and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants achieving functional cure (FC) with baseline HBsAg ≤3000 IU/mL (time frame: Up to 72 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05630807, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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