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Cure My Disease

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New drug aims to cure hepatitis b without lifelong pills

NCT ID NCT05630807

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial tests a drug called bepirovirsen in nearly 1,000 adults with chronic hepatitis B who are already on standard antiviral therapy. The goal is to see if bepirovirsen can suppress the virus enough that participants can safely stop all hepatitis B medications and remain virus-free. The study compares bepirovirsen to a placebo over about two years, with careful monitoring for safety and long-term response.

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 antiviral pills.
What could go wrong
This is an early Phase 3 trial; results may not confirm functional cure. Risks include side effects and that the virus may return 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

981 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) 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.

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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

    Chandler, Arizona, 85224, United States

  • GSK Investigational Site

    Davis, California, 95817, United States

  • GSK Investigational Site

    Los Angeles, California, 90027, United States

  • GSK Investigational Site

    Palo Alto, California, 94304, United States

  • GSK Investigational Site

    San Jose, California, 95116, United States

  • GSK Investigational Site

    Littleton, Colorado, 80120, United States

  • GSK Investigational Site

    Miami, Florida, 33134, United States

  • GSK Investigational Site

    Iowa City, Iowa, 52242, United States

  • GSK Investigational Site

    Baltimore, Maryland, 21287, United States

  • GSK Investigational Site

    Detroit, Michigan, 48377, United States

  • GSK Investigational Site

    Richmond, Virginia, 23249, United States

  • GSK Investigational Site

    Richmond, Virginia, 23298, United States

  • GSK Investigational Site

    Buenos Aires, 1061, Argentina

  • GSK Investigational Site

    Buenos Aires, C1061AAS, Argentina

  • GSK Investigational Site

    Buenos Aires, C1125ABE, Argentina

  • GSK Investigational Site

    Capital Federal, C1181ACI, Argentina

  • GSK Investigational Site

    Derqui Pilar, B1629AHJ, Argentina

  • GSK Investigational Site

    Rosario, S2002KDT, Argentina

  • GSK Investigational Site

    Aracaju, 49060-010, Brazil

  • GSK Investigational Site

    Campinas, 13034-685, Brazil

  • GSK Investigational Site

    Curitiba, 80810-050, Brazil

  • GSK Investigational Site

    Manaus, 69040-000, Brazil

  • GSK Investigational Site

    Porto Alegre, 90035003, Brazil

  • GSK Investigational Site

    Santa Maria, 97105-900, Brazil

  • GSK Investigational Site

    São Paulo, 05403-000, Brazil

  • GSK Investigational Site

    São Paulo, 08270-070, Brazil

  • GSK Investigational Site

    Vila Mariana, 04121-000, Brazil

  • GSK Investigational Site

    Sofia, 1431, Bulgaria

  • GSK Investigational Site

    Sofia, 1606, Bulgaria

  • GSK Investigational Site

    Sofia, Bulgaria

  • GSK Investigational Site

    Veliko Tarnovo, 5000, Bulgaria

  • GSK Investigational Site

    Vancouver, British Columbia, V6Z 2K5, Canada

  • GSK Investigational Site

    Victoria, British Columbia, V8V 3M9, Canada

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6, Canada

  • GSK Investigational Site

    Toronto, Ontario, M5G 2C4, Canada

  • GSK Investigational Site

    Montreal, Quebec, H2X 0A9, Canada

  • GSK Investigational Site

    Montreal, Quebec, H4A 3J1, Canada

  • GSK Investigational Site

    Québec, Quebec, G1V 4G2, Canada

  • GSK Investigational Site

    Saint-Jérôme, Quebec, J7Z 2V4, Canada

  • GSK Investigational Site

    Beijing, 100015, China

  • GSK Investigational Site

    Beijing, 100050, China

  • GSK Investigational Site

    Beijing, China

  • GSK Investigational Site

    Changchun, 130021, China

  • GSK Investigational Site

    Chengdu, China

  • GSK Investigational Site

    Chongqing, 400042, China

  • GSK Investigational Site

    Fuzhou, 350025, China

  • GSK Investigational Site

    Guangzhou, 510060, 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

    Kunming, 650021, China

  • GSK Investigational Site

    Nanjing, 210008, China

  • GSK Investigational Site

    Shanghai, 200025, China

  • GSK Investigational Site

    Shanghai, 200040, China

  • GSK Investigational Site

    Shanghai, 200083, China

  • GSK Investigational Site

    Shenyang, 110022, China

  • GSK Investigational Site

    Shenzhen, 518112, China

  • GSK Investigational Site

    Ürümqi, 830054, China

  • GSK Investigational Site

    Wuhan, 430022, China

  • GSK Investigational Site

    Xi'an, 710061, China

  • GSK Investigational Site

    Zhengzhou, 450000, China

  • GSK Investigational Site

    Zhenjiang, China

  • GSK Investigational Site

    Clermont-Ferrand, 63003, France

  • GSK Investigational Site

    Clichy, 92118, France

  • GSK Investigational Site

    Dijon, 21079, France

  • GSK Investigational Site

    Lille, 59037, France

  • GSK Investigational Site

    Pessac, 33604, France

  • GSK Investigational Site

    Poitiers, 86021, France

  • GSK Investigational Site

    Rennes, 35033, France

  • GSK Investigational Site

    Strasbourg, 67091, France

  • GSK Investigational Site

    Toulouse, 31059, France

  • GSK Investigational Site

    Berlin, 10243, Germany

  • GSK Investigational Site

    Berlin, 10439, Germany

  • GSK Investigational Site

    Berlin, 10787, Germany

  • GSK Investigational Site

    Berlin, 12163, Germany

  • GSK Investigational Site

    Bochum, 44787, Germany

  • GSK Investigational Site

    Cologne, 50668, Germany

  • GSK Investigational Site

    Düsseldorf, 40225, Germany

  • GSK Investigational Site

    München, 80336, Germany

  • GSK Investigational Site

    Athens, 10676, Greece

  • GSK Investigational Site

    Athens, 11527, Greece

  • GSK Investigational Site

    Periohi Dragana Alexand, 68100, Greece

  • GSK Investigational Site

    Rio Patras, 26504, Greece

  • GSK Investigational Site

    Kowloon, Hong Kong

  • GSK Investigational Site

    Pokfulam, Hong Kong

  • GSK Investigational Site

    Shatin, Hong Kong

  • GSK Investigational Site

    Budapest, 1097, Hungary

  • GSK Investigational Site

    Eger, 3300, Hungary

  • GSK Investigational Site

    Gyula, 5700, Hungary

  • GSK Investigational Site

    Miskolc, 3530, Hungary

  • GSK Investigational Site

    Belagavi, 590010, India

  • GSK Investigational Site

    Chandigarh, 160012, India

  • GSK Investigational Site

    Chennai, 600113, India

  • GSK Investigational Site

    Coimbatore, 641005, India

  • GSK Investigational Site

    Guhawati, 781006, India

  • GSK Investigational Site

    Hyderabad, 500033, India

  • GSK Investigational Site

    HyderabadTelangana, 500048, India

  • GSK Investigational Site

    Jaipur, 302001, India

  • GSK Investigational Site

    Ludhiana, 141001, India

  • GSK Investigational Site

    Manipal, 576104, India

  • GSK Investigational Site

    Mumbai, 400 008, India

  • GSK Investigational Site

    Mumbai, 400012, India

  • GSK Investigational Site

    Mumbai, 400026, India

  • GSK Investigational Site

    Pune, 411001, India

  • GSK Investigational Site

    Surat, 395002, India

  • GSK Investigational Site

    Brescia, 25123, Italy

  • GSK Investigational Site

    Foggia, 71100, Italy

  • GSK Investigational Site

    Messina, 98124, Italy

  • GSK Investigational Site

    Milan, 20122, Italy

  • GSK Investigational Site

    Milan, 20162, Italy

  • GSK Investigational Site

    Modena, 40126, Italy

  • GSK Investigational Site

    Chiba, 272-8516, Japan

  • GSK Investigational Site

    Ehime, 790-8524, Japan

  • GSK Investigational Site

    Fukuoka, 820-8505, Japan

  • GSK Investigational Site

    Fukuoka, 839-0863, Japan

  • GSK Investigational Site

    Gifu, 500-8717, Japan

  • GSK Investigational Site

    Gifu, 503-8502, Japan

  • GSK Investigational Site

    Hiroshima, 734-8551, Japan

  • GSK Investigational Site

    Hiroshima, 737-0023, Japan

  • GSK Investigational Site

    Hokkaido, 053-8506, Japan

  • GSK Investigational Site

    Hyōgo, 660-8550, Japan

  • GSK Investigational Site

    Kumamoto, 862-8655, Japan

  • GSK Investigational Site

    Miyagi, 980-8574, Japan

  • GSK Investigational Site

    Tokyo, 113-8519, Japan

  • GSK Investigational Site

    Tokyo, 173-8610, Japan

  • GSK Investigational Site

    Tokyo, 180-8610, Japan

  • GSK Investigational Site

    George Town, Malaysia

  • 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, Malaysia

  • GSK Investigational Site

    Kuantan, Malaysia

  • GSK Investigational Site

    Guadalajara, 44160, Mexico

  • GSK Investigational Site

    Oaxaca City, 68000, Mexico

  • GSK Investigational Site

    Panama City, 07206, Panama

  • GSK Investigational Site

    Bytom, 41-902, Poland

  • GSK Investigational Site

    Krakow, 31-202, Poland

  • GSK Investigational Site

    Łańcut, 37-100, Poland

  • GSK Investigational Site

    Bucharest, 021105, Romania

  • GSK Investigational Site

    Bucharest, 20125, Romania

  • GSK Investigational Site

    Cluj-Napoca, 400162, Romania

  • GSK Investigational Site

    Iași, 700116, Romania

  • GSK Investigational Site

    Suceava, 720224, Romania

  • GSK Investigational Site

    Timișoara, 300001, Romania

  • GSK Investigational Site

    Singapore, 119074, Singapore

  • GSK Investigational Site

    Singapore, 169608, Singapore

  • GSK Investigational Site

    Ansan, 15355, South Korea

  • GSK Investigational Site

    Busan, 47392, South Korea

  • GSK Investigational Site

    Daegu, 41944, South Korea

  • GSK Investigational Site

    Daegu, 42601, South Korea

  • GSK Investigational Site

    Seoul, 03080, South Korea

  • GSK Investigational Site

    Seoul, 06351, South Korea

  • GSK Investigational Site

    Seoul, 07061, South Korea

  • GSK Investigational Site

    Seoul, 08308, South Korea

  • GSK Investigational Site

    Barcelona, 08035, Spain

  • GSK Investigational Site

    Barcelona, 08036, Spain

  • GSK Investigational Site

    León, 24080, Spain

  • GSK Investigational Site

    Madrid, 28041, Spain

  • GSK Investigational Site

    Málaga, 29010, Spain

  • GSK Investigational Site

    Salamanca, 37007, Spain

  • GSK Investigational Site

    Santander, 39008, Spain

  • GSK Investigational Site

    Valencia, 46014, Spain

  • GSK Investigational Site

    Valladolid, 47003, Spain

  • GSK Investigational Site

    Vigo, 36002, Spain

  • GSK Investigational Site

    Kaohsiung City, 807, Taiwan

  • GSK Investigational Site

    Kaohsiung City, 833, Taiwan

  • GSK Investigational Site

    Taichung, 40705, Taiwan

  • GSK Investigational Site

    Taipei, 104, Taiwan

  • GSK Investigational Site

    Tau-Yuan, 333, Taiwan

  • GSK Investigational Site

    Bangkok, 10330, Thailand

  • GSK Investigational Site

    Ankara, 06230, Turkey (Türkiye)

  • GSK Investigational Site

    Birmingham, B15 2TH, United Kingdom

  • GSK Investigational Site

    Edinburgh, EH4 2XU, United Kingdom

  • GSK Investigational Site

    Leeds West Yorkshire, LS9 7TF, United Kingdom

  • GSK Investigational Site

    London, SE5 9RS, United Kingdom

  • GSK Investigational Site

    London, SW17 0QT, United Kingdom

More trials for these conditions

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