Hepatitis b drug combo trial halted early

NCT ID NCT05330455

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage study tested a new experimental drug called GSK3965193, alone and in combination with another drug (bepirovirsen), for people with chronic hepatitis B. The goal was to see if the combination could lower hepatitis B virus levels and possibly lead to a sustained response. However, the trial was terminated early, so we have very little information about whether the drugs are safe or effective.

What this could mean

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

Active substance
GSK3965193 and bepirovirsen
What this could lead to
If it had succeeded, this combination might have pointed toward a way to control chronic hepatitis B without lifelong medication.
What could go wrong
The trial was terminated early, so we don't know if the drug works or is safe. It was a very early (Phase 1/2) study with only 74 participants, so even if completed, results would be preliminary.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

74 people

The number who actually took part.

Started

Apr 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 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Parts 1 and 2: Participants between 18 and 55 years of age inclusive, at the time of signing the informed consent. * Parts 3 and 4: Participants between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Body weight \>=50 kilograms (kg) and body mass index within the range 18-32 kilograms per square meter (kg/m\^2) (inclusive). * Male or female participant: a. Parts 1 and 2: woman of nonchildbearing potential only. b. Parts 3 and 4: woman of nonchildbearing potential or woman of child-bearing potential who is not pregnant or breastfeeding and is using a contraceptive method that is highly effective. * Capable of giving signed informed consent. * Additional Inclusion Criteria for PLWCHB (Parts 3 and 4). * Participants who have documented chronic hepatitis B virus (HBV) infection \>=6 months prior to screening. * Participants currently receiving stable NA therapy (e.g., tenofovir disoproxil, tenofovir alafenamide, entecavir). * Plasma or serum HBsAg concentration \>100 IU/mL. * Plasma or serum HBV deoxyribonucleic acid (DNA) concentration \<90 IU/mL. * Hepatitis B virus e-antigen (HBeAg) positive or negative. * Alanine aminotransferase (ALT) \<=2 times the upper limit of normal (ULN) Exclusion Criteria: Exclusion Criteria for Healthy Participants: * Positive Hepatitis A virus antibody (HAV Ab immunoglobulin M \[IgM\]), or positive for HBV, hepatitis C virus (HCV) or human immunodeficiency virus (HIV) at screening * A current diagnosis of migraine headache * ALT \>1 times ULN. * Bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent \[%\]) * Corrected QT interval (QTc) \>450 milliseconds (msec) * Signs and symptoms suggestive of Coronavirus Disease 2019 (COVID-19) * Participants with known COVID-19 positive contacts in the past 14 days. * For participants in Part 2A: i. Personal history or family history of peripheral neuropathy. ii. A score ≥4 on the Toronto clinical scoring system for polyneuropathy * Current or previous use of tobacco- or nicotine-containing products (for example (e.g.) cigarettes, nicotine patches or electronic devices) within 6 months before screening and/or have a smoking pack history of \>5 pack years Exclusion Criteria for PLWCHB: * Clinically significant abnormalities affecting physical or mental health in medical history or on physical examination, aside from chronic HBV infection. * Co-infection with or past history of HCV, HIV or Hepatitis D virus (HDV). * 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 (e.g., skin cancer). * 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 Exclusion Criteria for Healthy Participants: * Positive Hepatitis A virus antibody (HAV Ab immunoglobulin M \[IgM\]), or positive for HBV, hepatitis C virus (HCV) or human immunodeficiency virus (HIV) at screening. * A current diagnosis of migraine headache * ALT \>1 times ULN. * Bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent \[%\]). * Corrected QT interval (QTc) \>450 milliseconds (msec). * Signs and symptoms suggestive of Coronavirus Disease 2019 (COVID-19). * Participants with known COVID-19 positive contacts in the past 14 days. * For participants in Part 2A: i. Personal history or family history of peripheral neuropathy. ii. A score ≥4 on the Toronto clinical scoring system for polyneuropathy. * Current or previous use of tobacco- or nicotine-containing products (for example (e.g.) cigarettes, nicotine patches or electronic devices) within 6 months before screening and/or have a smoking pack history of \>5 pack years Exclusion Criteria for PLWCHB: * Clinically significant abnormalities affecting physical or mental health in medical history or on physical examination, aside from chronic HBV infection. * Co-infection with or past history of HCV, HIV or Hepatitis D virus (HDV). * 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 (e.g., skin cancer). * 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, cryoglobulinaemia, uncontrolled hypertension). * History of alcohol or drug abuse/dependence: a. Current alcohol use as judged by investigator to potentially interfere with participant compliance. b. History of or current drug abuse/dependence as judged by the investigator to potentially interfere with participant compliance. * History or other evidence of bleeding from esophageal varices. * Documented history or other evidence of metabolic liver disease within 1 year of randomization. * Personal history or family history of peripheral neuropathy. * A score \>4 on the Toronto clinical scoring system for polyneuropathy. * History of having received or currently receiving any systemic anti-neoplastic (including radiation) or immune-modulatory treatment (including systemic oral corticosteroids, interferon or pegylated interferon) within the 3 months prior to randomization or the expectation that such treatment will be needed at any time during the study. * Abnormal and clinically significant 12-lead ECG finding. * Currently taking, or taken within 3 months prior to randomization, any immunosuppressing drugs (e.g., prednisone), other than a short course of therapy (≤2 weeks) or topical/inhaled steroid use. * Participants requiring anti-coagulation therapies. * Prior treatment with any oligonucleotide or small interfering RNA (siRNA) within 12 months prior to the first dosing day. * Positive test for COVID-19 infection.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • GSK Investigational Site

    Calgary, Alberta, T2N 4Z6, Canada

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6, Canada

  • GSK Investigational Site

    Grenoble, 38043, France

  • GSK Investigational Site

    Nantes, 44000, France

  • GSK Investigational Site

    Rennes, 35033, France

  • GSK Investigational Site

    Milan, 20122, Italy

  • GSK Investigational Site

    Monza MB, 20900, Italy

  • GSK Investigational Site

    Daegu, 41944, South Korea

  • GSK Investigational Site

    Pusan, 49241, South Korea

  • GSK Investigational Site

    Seoul, 05505, South Korea

  • GSK Investigational Site

    Bangkok, 10330, Thailand

  • GSK Investigational Site

    Cambridge, CB2 2GG, United Kingdom

  • GSK Investigational Site

    London, SW17 0QT, United Kingdom

  • GSK Investigational Site

    London, W2 1NY, United Kingdom

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