Hepatitis b drug combo trial halted early
NCT ID NCT05330455
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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74 people
The number who actually took part.
- Started
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Apr 2022
- Finished
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Apr 2026
- Lead sponsor
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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
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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GSK Investigational Site
Calgary, Alberta, T2N 4Z6, Canada
-
GSK Investigational Site
Ottawa, Ontario, K1H 8L6, Canada
-
GSK Investigational Site
Grenoble, 38043, France
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GSK Investigational Site
Nantes, 44000, France
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GSK Investigational Site
Rennes, 35033, France
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GSK Investigational Site
Milan, 20122, Italy
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GSK Investigational Site
Monza MB, 20900, Italy
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GSK Investigational Site
Daegu, 41944, South Korea
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GSK Investigational Site
Pusan, 49241, South Korea
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GSK Investigational Site
Seoul, 05505, South Korea
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GSK Investigational Site
Bangkok, 10330, Thailand
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GSK Investigational Site
Cambridge, CB2 2GG, United Kingdom
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GSK Investigational Site
London, SW17 0QT, United Kingdom
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GSK Investigational Site
London, W2 1NY, United Kingdom
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