Chronic Hepatitis B
Conditions
Interventions
Two 1 ml subcutaneous injections per visit, 14x
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Men and women >= 18 years of age 2. documented chronic HBV infection >=6 months prior to screening AND currently receiving stable nucleotide analogue therapy (no changes to the nucleos(t)ide regimen from at least 6 months prior to screening and with no planned changes to the stable regimen over the duration of the study) 3. Plasma or serum HBsAg concentration >100 IU/mL. 4. Plasma or serum HBV DNA concentration must be adequately suppressed 5. HBeAg-negative 6. Alanine Transaminase (ALT)
Exclusion criteria
Exclusion criteria: 1. Clinically significant abnormalities, aside from chronic HBV infection in medical history or physical examination 2. Co-infection with Current or past history of HCV or with HIV or HDV 3. History of or suspected liver cirrhosis and/or evidence of cirrhosis 4. Diagnosed or suspected hepatocellular carcinoma 5. History of malignancy within the past 5 years with the exception of specific cancers that are cured by surgical resection 6. History of vasculitis or presence of symptoms and signs of potential vasculitis 7. History of extrahepatic disorders possibly related to HBV immune conditions 8. History of alcohol or drug abuse/dependence 9. Currently taking, or took within 3 months of screening, any immunosuppressing drugs 10. Participants for whom immunosuppressive treatment is not advised, including therapeutic doses of steroids, will be excluded 11. Currently taking, or took within 12 months of screening, any interferon-containing therapy. 12. Participant requiring anti-coagulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary estimand is the percentage of participants with CHB receiving 300 mg GSK3228836 for 12 weeks (with at least one dose of IP) who achieve serum HBsAg level | — |
Secondary
| Measure | Time frame |
|---|---|
| o Sustained HBsAg Response (HBsAg 3X ULN at over time . HBe antibody (anti-HBeAg) levels over time Variables: • Actual values and change from baseline over time for HBsAg and HBV DNA • HBs antibody (anti-HBsAg) and HBe antibody (anti-HBeAg) levels over time • Area under the curve (AUC) for ALT on treatment (12 weeks), during follow up (24 weeks), and on treatment + follow up (36 weeks). Time to Event Variable • Time to Maximum ALT (ALT must be greater than 3xULN) during 36 weeks of treatment + follow up | — |
Countries
Netherlands
Outcome results
None listed