A study on the safety, efficacy and immune response following sequential treatment with an anti-sense oligonucleotide against chronic Hepatitis B (CHB) and chronic Hepatitis B targeted immunotherapy (CHB-TI) in CHB patients receiving nucleos(t)ide analogue (NA) therapy.

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• "Medical conditions • Clinically significant abnormalities, aside from chronic HBV infection in medical history • Co-infection with:  Current or past history of Hepatitis C virus (HCV)  Human immunodeficiency virus (HIV)  Hepatitis D virus (HDV) • History of or suspected liver cirrhosis and/or evidence of cirrhosis as determined by  both Aspartate aminotransferase (AST)-Platelet Index (APRI) >2 and FibroSure/FibroTest result >0.7  Regardless of APRI or Fibrosure/FibroTest score, if the participant meets one of the following historical criteria, they will be excluded from the study o Liver biopsy (i.e., METAVIR Score F4) o Liver stiffness >12 kPa • FibroScan TE score >9.6 kPa and FibroTest score >0.59 at Screening. • Diagnosed or suspected HCC as evidenced by the following:  Alpha-fetoprotein concentration ≥200 ng/mL  If the screening alpha-fetoprotein concentration is ≥50 ng/mL and <200 ng/mL, the absence of liver mass must be documented by imaging within 6 months before randomisation. • History of malignancy within the past 5 years with the exception of specific cancers that are cured by surgical resection. • History of vasculitis or presence of symptoms and signs of potential vasculitis. • History of extrahepatic disorders possibly related to HBV immune conditions. • Positive (or borderline positive) Anti-neutrophil cytoplasmic antibody (ANCA) at screening: • Low C3/C4 at screening AND evidence of past history or current manifestations of vasculitic/inflammatory/autoimmune conditions • History of alcohol or drug abuse/dependence • Fridericia’s QT correction formula (QTcF) ≥450 msec • Laboratory results as follows:  Serum albumin <3.5 g/dL  Glomerular filtration rate (GFR) <60 mL/ min /1.73m2 as calculated by the Chronic Kidney Disease Epidemiologic Collaboration (CKD-EPI) formula  INR >1.25  Platelet count <140x109/L  Haemoglobin< 10 g/dl  Total bilirubin >1.25xULN  Urine albumin to creatinine ratio (ACR) ≥0.03 mg/mg (or ≥30 mg/g). • Medical history of hepatic decompensation. • Planned for liver transplantation or previous liver transplantation. • Documented evidence of other currently active cause of hepatitis • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. • Major congenital defects, as assessed by the Investigator. • Recurrent history or uncontrolled neurological disorders or seizures. • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s)."
• "Prior/Concomitant therapy • Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the first dose of study interventions, or their planned use during the study period. • Use of systemic cytotoxic agents, chronic antiviral agents or Chinese herbal medicines which may have activity against HBV within the previous 6 months. • Currently taking, or took within 12 months of screening, any interferon-containing therapy. • Administration of adenovirus/adenovector-based or MVA-based vaccine within the last 12 months, except for adenovirus/adenovector-based Coronavirus Disease 2019 (COVID-19) vaccines that could be administered up to 30 days prior to the first study vaccine dose (applicable for all patients except for the patients in France) OR Administration of adenovirus/adenovector-based or MVA-based vaccine within the last 12 months (applicable for the patients in France only). • Planned administration/administration of a vaccine/product not foreseen by the study protocol in the period starting 14 days before the first dose and ending 30 days after the last dose of study intervention administration, with the exception of influenza vaccine that may be given at any time except within a 7-day period before or after each dose and COVID-19 vaccine that may be given at any time except within a 30-day period before or after each vaccine dose apart from COVID-19 messenger ribonucleic acid (mRNA) based-vaccines that may be administered any time except for the period of 14 days before and 30 days after each study vaccine dose."
• "• Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab). • Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study interventions or planned administration during the study period. • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose(s). For corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants (≥10 mg/day applicable in Germany only). Inhaled and topical steroids are allowed. • Participants for whom immunosuppressive treatment is not advised, including therapeutic doses of corticosteroids, will be excluded. • Treatment with nephrotoxic drugs or competitors of renal excretion within 2 months prior to Screening. • Participants requiring anti-coagulation therapies."
• "Prior/Concurrent clinical study experience: • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device). • Previous participation in clinical trials with administration of either GSK3228836 or GSK3528869A. • Previous participation in a clinical study in which he/she has received an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives (if known) or twice the duration (if known) of the biological effect of the study treatment (whichever is longer) or 90 days (if half-life or duration is unknown). • Prior treatment with any other oligonucleotide or small interfering RNA (siRNA) within 12 months prior to the first dosing day. Other exclusions: • Pregnant or lactating female. • Female planning to become pregnant/to discontinue contraceptive precautions. • Any study personnel or their immediate dependents, family, or household members. • History of/sensitivity to GSK3228836, or components thereof, or a history of drug or other allergy that contraindicates their participation."