Informations générales (source: ClinicalTrials.gov)
A Phase 2b, Multi-centre, Randomized, Partially Placebo-controlled, Double-blind Study to Investigate the Safety and Efficacy of Sequential Therapy With Daplusiran/Tomligisiran Followed by Bepirovirsen in Participants With Chronic Hepatitis B Virus on Background Nucleos(t)Ide Analogue Therapy (B-United)
Interventional
Phase 2
GlaxoSmithKline (Voir sur ClinicalTrials)
novembre 2024
mai 2027
16 septembre 2025
The study is intended to evaluate the efficacy and safety of 2 different doses of DAP/TOM
followed by bepirovirsen in participants living with CHB on standard of care
nucleos(t)ide analogue (NA) therapy. The study also aims to identify an optimal dose of
DAP/TOM for sequenced therapy with bepirovirsen for further clinical development and to
assess the contribution of DAP/TOM to the sequential regimen.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Isabelle ROSA | 28/08/2025 15:25:02 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| GSK Investigational Site - 13008 - Marseille - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 31059 - Toulouse Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 69004 - Lyon - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 87042 - Limoges cedex - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 92118 - Clichy Cedex - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 94010 - CrEteil cedex - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Age: At least 18 years of age at the time of signing the informed consent.
- Documented chronic HBV infection >=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 >100 international units per milliliter (IU/mL)
- Plasma or serum HBV DNA concentration must be adequately suppressed, defined as
plasma or serum HBV DNA <90 IU/mL.
- Alanine aminotransferase <=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
- Age: At least 18 years of age at the time of signing the informed consent.
- Documented chronic HBV infection >=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 >100 international units per milliliter (IU/mL)
- Plasma or serum HBV DNA concentration must be adequately suppressed, defined as
plasma or serum HBV DNA <90 IU/mL.
- Alanine aminotransferase <=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
- 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 ribonucleic acid (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.