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Two-Drug combo aims to cure chronic hepatitis b

NCT ID NCT06537414

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study tests whether giving two experimental drugs in sequence can achieve a functional cure for chronic hepatitis B. Participants are adults with chronic HBV who are already on standard antiviral therapy. They will receive either one of two doses of daplusiran/tomligisiran followed by bepirovirsen, or a placebo, to see if the combination can suppress the virus long-term without ongoing treatment.

What this could mean

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

Active substance
Daplusiran/Tomligisiran and Bepirovirsen
What this could lead to
If successful, this sequential therapy could offer a functional cure for chronic hepatitis B, allowing patients to stop all treatments while keeping the virus suppressed.
What could go wrong
This is a Phase 2b trial, so the approach is still experimental. It may not achieve sustained viral suppression, and side effects from the drug combination are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

283 people

The number who actually took part.

Started

Nov 2024

Expected to finish

May 2030

An estimate. End dates often move.

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: * Age: At least 18 years of age at the time of signing the informed consent * Documented chronic HBV infection greater than or equal to (\>=) 6 months prior to Screening AND currently receiving stable NA therapy defined as receiving an NA regimen form at least 6 months prior to Screening and with no planned changes to their stable regimen over the duration of the study. * Plasma or serum HBsAg concentration greater than (\>) 100 international units per milliliter (IU/mL) * Plasma or serum HBV DNA concentration must be adequately suppressed, defined as plasma or serum HBV DNA less than (\<) 90 IU/mL * Alanine aminotransferase less than or equal to (\<=) 2\* upper limit of normal (ULN) * Participants who are willing and able to cease their NA treatment in accordance with the protocol. * Male and Female 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 coagulopathy) or clinically significant physical examination findings. * Coinfection with Hepatitis C (cured \<12 months at the time of screening), Human immunodeficiency virus or 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 with the exception of specific cancers that are cured by surgical resection (example, 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 (example, systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex). * History of extrahepatic disorders possibly related to HBV immune conditions (example, 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 (example, 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 enrollment in the study. * Currently taking, or has taken within 6 months of Screening, any interferon-containing therapy. * Participants requiring anti-coagulation therapies (example, warfarin, Factor Xa inhibitors) or anti-platelet agents (like clopidogrel or aspirin) unless treatment can safely be discontinued throughout duration of Investigational medicinal product (IMP) treatment, by the discretion of the investigator. Occasional use is permitted. * Prior hepatitis B treatment with bepirovirsen, DAP/TOM, or another oligonucleotide or small interfering RNA (siRNA). * Prior non-hepatitis B treatment with an oligonucleotide or siRNA within 12 months prior to the first dosing day. * Fridericia's QT correction formula (QTcF) \>=450 millisecond (msec) (if single electrocardiogram \[ECG\] at screening shows QTcF \>=450 msec, a mean of triplicate measurements should be used to confirm that participant meets exclusion criterion). * History of/sensitivity to bepirovirsen, DAP/TOM or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation * Participants who do not wish to discontinue taking NA therapy for their chronic HBV infection.

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection

As listed by the trial registrant

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

Chronic hepatitis B virus infection Hepatitis B

Contacts and locations

Locations

  • GSK Investigational Site

    San Francisco, California, 94115, United States

  • GSK Investigational Site

    San Jose, California, 95116, United States

  • GSK Investigational Site

    Minneapolis, Minnesota, 55415, United States

  • GSK Investigational Site

    New York, New York, 10029, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104, United States

  • GSK Investigational Site

    Westmead, New South Wales, 2145, Australia

  • GSK Investigational Site

    Fitzroy, Victoria, 3065, Australia

  • GSK Investigational Site

    Brussels, 1000, Belgium

  • GSK Investigational Site

    Edegem, 2650, Belgium

  • GSK Investigational Site

    Ghent, 9000, Belgium

  • GSK Investigational Site

    Aracaju, 49060-010, Brazil

  • GSK Investigational Site

    Curitiba, 80810-050, Brazil

  • GSK Investigational Site

    Manaus, 69040-000, Brazil

  • GSK Investigational Site

    São Paulo, 05403-000, Brazil

  • GSK Investigational Site

    Calgary, Alberta, T2N 4Z6, Canada

  • GSK Investigational Site

    Ottawa, Ontario, K1H8L6, Canada

  • GSK Investigational Site

    Toronto, Ontario, M5G 2C4, Canada

  • GSK Investigational Site

    Montreal, Quebec, H4A 3J1, Canada

  • GSK Investigational Site

    Beijing, 100050, China

  • GSK Investigational Site

    Chengdu, 610072, China

  • GSK Investigational Site

    Guangzhou, 510630, China

  • GSK Investigational Site

    Shanghai, 200040, China

  • GSK Investigational Site

    Clichy, 92118, France

  • GSK Investigational Site

    Créteil, 94010, France

  • GSK Investigational Site

    Limoges, 87042, France

  • GSK Investigational Site

    Lyon, 69004, France

  • GSK Investigational Site

    Marseille, 13008, France

  • GSK Investigational Site

    Berlin, 10439, Germany

  • GSK Investigational Site

    Berlin, 10787, Germany

  • GSK Investigational Site

    Hanover, 30625, Germany

  • GSK Investigational Site

    Münster, 48149, Germany

  • GSK Investigational Site

    Athens, 10676, Greece

  • GSK Investigational Site

    Athens, 11527, Greece

  • GSK Investigational Site

    Pokfulam, Hong Kong

  • GSK Investigational Site

    Shatin, Hong Kong

  • GSK Investigational Site

    Bergamo, 24127, Italy

  • GSK Investigational Site

    Florence, 50134, Italy

  • GSK Investigational Site

    Milan, Italy

  • GSK Investigational Site

    Naples, 80131, Italy

  • GSK Investigational Site

    Padova, 35131, Italy

  • GSK Investigational Site

    Pisa, 56124, Italy

  • GSK Investigational Site

    Roma, 00161, Italy

  • GSK Investigational Site

    Chiba, 270-1694, Japan

  • GSK Investigational Site

    Hokkaido, 006-8555, Japan

  • GSK Investigational Site

    Hokkaido, 053-8506, Japan

  • GSK Investigational Site

    Hyōgo, 660-8550, Japan

  • GSK Investigational Site

    Kagawa, 760-8557, Japan

  • GSK Investigational Site

    Kagawa, 761-0793, Japan

  • GSK Investigational Site

    Kumamoto, 860-8556, Japan

  • GSK Investigational Site

    Kumamoto, 862-8655, Japan

  • GSK Investigational Site

    Osaka, 540-0006, Japan

  • GSK Investigational Site

    Osaka, 565-0871, Japan

  • GSK Investigational Site

    Tokyo, 180-8610, Japan

  • GSK Investigational Site

    Yamanashi, 409-3898, Japan

  • GSK Investigational Site

    Auckland, 1023, New Zealand

  • GSK Investigational Site

    Papatoetoe Auckland, 2025, New Zealand

  • GSK Investigational Site

    Singapore, 119074, Singapore

  • GSK Investigational Site

    Singapore, 169608, Singapore

  • GSK Investigational Site

    Johannesburg, 2193, South Africa

  • GSK Investigational Site

    Reiger Park, 1459, South Africa

  • GSK Investigational Site

    Ansan, 15355, South Korea

  • GSK Investigational Site

    Busan, 47392, South Korea

  • GSK Investigational Site

    Pusan, 49241, South Korea

  • GSK Investigational Site

    Seoul, 07061, South Korea

  • GSK Investigational Site

    Seoul, 138-736, 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

    Salamanca, 37007, Spain

  • GSK Investigational Site

    Santander, 39008, Spain

  • GSK Investigational Site

    Valencia, 46026, Spain

  • GSK Investigational Site

    Kaohsiung City, 807, Taiwan

  • GSK Investigational Site

    Kaohsiung City, 824, Taiwan

  • GSK Investigational Site

    Taichung, 404, Taiwan

  • GSK Investigational Site

    Tau-Yuan, 333, Taiwan

  • GSK Investigational Site

    London, E1 8PR, United Kingdom

  • GSK Investigational Site

    London, SE5 9RS, United Kingdom

  • GSK Investigational Site

    London, SW17 0QT, United Kingdom

  • GSK Investigational Site

    Middlesbrough, TS4 3BW, United Kingdom

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