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New drug aims to free hepatitis b patients from daily pills

NCT ID NCT05630820

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This Phase 3 study tests bepirovirsen, an experimental drug, in 857 adults with chronic hepatitis B who are already on standard antiviral therapy. The goal is to see if bepirovirsen can suppress the virus enough to allow patients to stop all hepatitis B treatments and remain virus-free. The study compares bepirovirsen to a placebo over 24 weeks, followed by monitoring for up to 104 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bepirovirsen
What this could lead to
If successful, this could offer a finite treatment that controls hepatitis B without needing lifelong medication, potentially leading to a functional cure.
What could go wrong
This is a Phase 3 trial, but functional cure is difficult to achieve; many participants may not respond, and there is risk of side effects or virus reactivation after stopping treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

857 people

The number who actually took part.

Started

Dec 2022

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. 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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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis hepatitis B virus infection Hepatitis, Chronic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic hepatitis B Hepatitis B, chronic

Contacts and locations

Locations

  • GSK Investigational Site

    Centreville, Alabama, 35042, United States

  • GSK Investigational Site

    Los Angeles, California, 90033, United States

  • GSK Investigational Site

    San Francisco, California, 94115, United States

  • GSK Investigational Site

    San Francisco, California, 94121, United States

  • GSK Investigational Site

    Colorado Springs, Colorado, 80907, United States

  • GSK Investigational Site

    Ft. Pierce, Florida, 34982, United States

  • GSK Investigational Site

    Miami, Florida, 33136, United States

  • GSK Investigational Site

    Glen Burnie, Maryland, 21061, United States

  • GSK Investigational Site

    Minneapolis, Minnesota, 55404, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104, United States

  • GSK Investigational Site

    Denison, Texas, 75020, United States

  • GSK Investigational Site

    Seattle, Washington, 98104, United States

  • GSK Investigational Site

    Buenos Aires, 1023, Argentina

  • GSK Investigational Site

    Buenos Aires, C1425AGC, Argentina

  • GSK Investigational Site

    Ciudad Autonoma de Bueno, C1056ABI, Argentina

  • GSK Investigational Site

    Santa Fe, 3000, Argentina

  • GSK Investigational Site

    Westmead, New South Wales, 2145, Australia

  • GSK Investigational Site

    Herston, Queensland, 4029, Australia

  • GSK Investigational Site

    Box Hill, Victoria, 3128, Australia

  • GSK Investigational Site

    Fitzroy, Victoria, 3065, Australia

  • GSK Investigational Site

    Botucatu, 18618-686, Brazil

  • GSK Investigational Site

    Fortaleza, 60430-372, Brazil

  • GSK Investigational Site

    Nova Iguaçu, 26030-380, Brazil

  • GSK Investigational Site

    Porto Alegre, 90020-090, Brazil

  • GSK Investigational Site

    Porto Alegre, 90035003, Brazil

  • GSK Investigational Site

    Rio de Janeiro, 21045-900, Brazil

  • GSK Investigational Site

    Salvador, 40110160, Brazil

  • GSK Investigational Site

    Vitória, 29043260, Brazil

  • GSK Investigational Site

    Plovdiv, 4002, Bulgaria

  • GSK Investigational Site

    Sliven, 8800, Bulgaria

  • GSK Investigational Site

    Sofia, 1797, Bulgaria

  • GSK Investigational Site

    Varna, 9020, Bulgaria

  • GSK Investigational Site

    Calgary, Alberta, T2N 4N1, Canada

  • GSK Investigational Site

    Edmonton, Alberta, T6G 2B7, Canada

  • GSK Investigational Site

    Edmonton, Alberta, T6G 2X8, Canada

  • GSK Investigational Site

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • GSK Investigational Site

    Toronto, Ontario, M6H 3M1, Canada

  • GSK Investigational Site

    Montreal, Quebec, H2L 4E9, Canada

  • GSK Investigational Site

    Montreal, Quebec, H2L 4P9, Canada

  • GSK Investigational Site

    Regina, Saskatchewan, S4P 0W5, Canada

  • GSK Investigational Site

    Beijing, 100015, China

  • GSK Investigational Site

    Beijing, 100032, China

  • GSK Investigational Site

    Changchun, 130021, China

  • GSK Investigational Site

    Chengdu, 610072, China

  • GSK Investigational Site

    Chongqing, 400042, China

  • GSK Investigational Site

    Guangzhou, 510515, China

  • GSK Investigational Site

    Guangzhou, 510630, China

  • GSK Investigational Site

    Hangzhou, 310003, China

  • GSK Investigational Site

    Hangzhou, 310022, China

  • GSK Investigational Site

    Hefei, 230022, China

  • GSK Investigational Site

    Kunming, 650021, China

  • GSK Investigational Site

    Liuzhou, 545006, China

  • GSK Investigational Site

    Nanjing, 210003, China

  • GSK Investigational Site

    Shanghai, 200025, China

  • GSK Investigational Site

    Shanghai, 200052, China

  • GSK Investigational Site

    Shenzhen, 518112, China

  • GSK Investigational Site

    Taiyuan, 030001, China

  • GSK Investigational Site

    Tianjin, 300000, China

  • GSK Investigational Site

    Ürümqi, 830054, China

  • GSK Investigational Site

    Wuhan, 430022, China

  • GSK Investigational Site

    Xi'an, 710061, China

  • GSK Investigational Site

    Xiamen, 361015, China

  • GSK Investigational Site

    Zhengzhou, 450000, China

  • GSK Investigational Site

    Zunyi, 563114, China

  • GSK Investigational Site

    Créteil, 94010, France

  • GSK Investigational Site

    Grenoble, 38043, France

  • GSK Investigational Site

    Limoges, 87042, France

  • GSK Investigational Site

    Lyon, 69317, France

  • GSK Investigational Site

    Paris, 75651, France

  • GSK Investigational Site

    Rouen, 76031, France

  • GSK Investigational Site

    Toulouse, 31059, France

  • GSK Investigational Site

    Frankfurt, 60329, Germany

  • GSK Investigational Site

    Frankfurt, 60596, Germany

  • GSK Investigational Site

    Hamburg, 20146, Germany

  • GSK Investigational Site

    Hanover, 30625, Germany

  • GSK Investigational Site

    Athens, 115 27, Greece

  • GSK Investigational Site

    Heraklion Crete, 715 00, Greece

  • GSK Investigational Site

    Thessaloniki, 54642, Greece

  • GSK Investigational Site

    Szeged, 6725, Hungary

  • GSK Investigational Site

    Székesfehérvár, 8000, Hungary

  • GSK Investigational Site

    Zalaegerszeg, Hungary

  • GSK Investigational Site

    Ahmedabad, 380009, India

  • GSK Investigational Site

    Chennai, 600035, India

  • GSK Investigational Site

    Kanpur, 208002, India

  • GSK Investigational Site

    Kochi, 682026, India

  • GSK Investigational Site

    Kolkata, 700150, India

  • GSK Investigational Site

    Kolkata, India

  • GSK Investigational Site

    Mumbai, 400012, India

  • GSK Investigational Site

    Mumbai, 400022, India

  • GSK Investigational Site

    Nagpur, 441108, India

  • GSK Investigational Site

    New Delhi, 110029, India

  • GSK Investigational Site

    New Delhi, 110060, India

  • GSK Investigational Site

    New Delhi, 110070, India

  • GSK Investigational Site

    Pune, 411001, India

  • GSK Investigational Site

    Raipur, India

  • GSK Investigational Site

    Secunderabad, 500003, India

  • GSK Investigational Site

    Milan, 20157, Italy

  • GSK Investigational Site

    Naples, 80131, Italy

  • GSK Investigational Site

    Padova, 35128, Italy

  • GSK Investigational Site

    Palermo, 90127, Italy

  • GSK Investigational Site

    Pisa, 56124, Italy

  • GSK Investigational Site

    Roma, 00133, Italy

  • GSK Investigational Site

    Sassari, 07100, Italy

  • GSK Investigational Site

    Torino, 10126, Italy

  • GSK Investigational Site

    Fukui, 918-8503, Japan

  • GSK Investigational Site

    Hiroshima, 730-8619, Japan

  • GSK Investigational Site

    Hokkaido, 006-8555, Japan

  • GSK Investigational Site

    Hokkaido, 060-8648, Japan

  • GSK Investigational Site

    Hokkaido, 062-8618, Japan

  • GSK Investigational Site

    Ishikawa, 920-8650, Japan

  • GSK Investigational Site

    Kagawa, 760-8557, Japan

  • GSK Investigational Site

    Kumamoto, 860-8556, Japan

  • GSK Investigational Site

    Nagasaki, 856-8562, Japan

  • GSK Investigational Site

    Nara, 634-8522, Japan

  • GSK Investigational Site

    Niigata, 950-1104, Japan

  • GSK Investigational Site

    Osaka, 565-0871, Japan

  • GSK Investigational Site

    Tokyo, 113-8603, Japan

  • GSK Investigational Site

    Yamaguchi, 750-0061, Japan

  • GSK Investigational Site

    Yamanashi, 409-3898, Japan

  • GSK Investigational Site

    Johor Bahru, 80100, Malaysia

  • GSK Investigational Site

    Kota Bharu Kelantan, Malaysia

  • GSK Investigational Site

    Kota Kinabalu, Malaysia

  • GSK Investigational Site

    Kuala Lumpur, 59100, Malaysia

  • GSK Investigational Site

    Kuala Terengganu, 20400, Malaysia

  • GSK Investigational Site

    Kuantan, 25100, Malaysia

  • GSK Investigational Site

    Aguascalientes, 20010, Mexico

  • GSK Investigational Site

    Auckland, 1023, New Zealand

  • GSK Investigational Site

    Auckland, 2025, New Zealand

  • GSK Investigational Site

    Panama City, Panama

  • GSK Investigational Site

    Cebu City, 6000, Philippines

  • GSK Investigational Site

    Makati City, 1229, Philippines

  • GSK Investigational Site

    Pasig, 1605, Philippines

  • GSK Investigational Site

    Silang, 4118, Philippines

  • GSK Investigational Site

    Gdansk, 80-405, Poland

  • GSK Investigational Site

    Mysłowice, 41-400, Poland

  • GSK Investigational Site

    Żychlin, 62-571, Poland

  • GSK Investigational Site

    Bucharest, 020475, Romania

  • GSK Investigational Site

    Bucharest, 030303, Romania

  • GSK Investigational Site

    Cluj-Napoca, 400348, Romania

  • GSK Investigational Site

    Constanța, 900709, Romania

  • GSK Investigational Site

    Galati, 800179, Romania

  • GSK Investigational Site

    Oradea, 410469, Romania

  • GSK Investigational Site

    Ansan, 15355, South Korea

  • GSK Investigational Site

    Incheon, 405-760, South Korea

  • GSK Investigational Site

    Pusan, 49241, South Korea

  • GSK Investigational Site

    Seoul, 03312, South Korea

  • GSK Investigational Site

    Seoul, 05505, South Korea

  • GSK Investigational Site

    Ulsan, 44033, South Korea

  • GSK Investigational Site

    Alcorcon Madrid, Spain

  • GSK Investigational Site

    Badajoz, 06080, Spain

  • GSK Investigational Site

    Granada, 18016, Spain

  • GSK Investigational Site

    Madrid, 28006, Spain

  • GSK Investigational Site

    Madrid, 28032, Spain

  • GSK Investigational Site

    Madrid, 28046, Spain

  • GSK Investigational Site

    Sabadell Barcelona, 08208, Spain

  • GSK Investigational Site

    Seville, 41013, Spain

  • GSK Investigational Site

    Valencia, 46026, Spain

  • GSK Investigational Site

    Valladolid, 47012, Spain

  • GSK Investigational Site

    Zaragoza, 50009, Spain

  • GSK Investigational Site

    Kaohsiung City, 824, Taiwan

  • GSK Investigational Site

    Taichung, 404, Taiwan

  • GSK Investigational Site

    Tainan, 704, Taiwan

  • GSK Investigational Site

    Taipei, 100, Taiwan

  • GSK Investigational Site

    Chiang Mai, 50200, Thailand

  • GSK Investigational Site

    Ankara, 06590, Turkey (Türkiye)

  • GSK Investigational Site

    Istanbul, 34010, Turkey (Türkiye)

  • GSK Investigational Site

    Izmir, 35100, Turkey (Türkiye)

  • GSK Investigational Site

    Liverpool, L7 8XP, United Kingdom

  • GSK Investigational Site

    London, WC1E 6JB, United Kingdom

  • GSK Investigational Site

    Middlesbrough, TS4 3BW, United Kingdom

  • GSK Investigational Site

    Newcastle upon Tyne, NE7 7DN, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.