drugset / Trial / NCT05276297
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
RandomizedSequentialSingle-blindTreatment
Summary
This study will assess the safety, efficacy and immune response following the sequential treatment of GlaxoSmithKline's (GSK) ASO compound (GSK3228836) and CHB-TI (GSK3528869A) in participants 18 to 65 years stable on NA treatment for CHB. The aim is to quantify the efficacy of sequential therapy as well as to determine an added value of sequential therapy over GSK3228836 therapy in CHB patients treated with NAs. In addition, the study will assess the effect of different treatment durations of GSK3228836 (12 or 24 weeks) prior to initiating GSK3528869A treatment.
Timeline
- Start
- 2022-03-22
- Primary completion
- 2025-08-05
- Completion
- 2025-08-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bepirovirsen | Antisense oligonucleotide | — | Subcutaneous |
| Subject | ChAd155-hIi-HBV | Vaccine | — | Intramuscular |
| Subject | HBc-HBs/AS01B-4 | Vaccine | — | Intramuscular |
| Subject | MVA-HBV | Vaccine | — | Intramuscular |