Full name
A Phase 2, Single-blinded, Randomised, Controlled Multi-country Study to Evaluate the Safety, Reactogenicity, Efficacy and Immune Response Following Sequential Treatment With an Anti-sense Oligonucleotide (ASO) Against Chronic Hepatitis B (CHB) Followed by Chronic Hepatitis B Targeted Immunotherapy (CHB-TI) in CHB Patients Receiving Nucleos(t)Ide Analogue (NA) Therapy
NCT Number
NCT05276297
Geography
US
Locations
Belgium, Bulgaria, France, Germany, Hong Kong, Italy, Philippines, Poland, Romania, Singapore, Spain, Taiwan, Thailand, Turkey, United Kingdom
Primary Endpoints
- Percentage of participants reporting any grade 3 adverse event (AE) from first dose of GSK3228836 up to study end. From first dose of GSK3228836 (Treatment 1 [T1]-Day 1) up to study end (Treatment 2 [T2]-Day 841)
- Percentage of participants reporting any serious adverse event (SAE) from first dose of GSK3228836 up to study end. From first dose of GSK3228836 (Treatment 1-Day 1) up to study end (Treatment 2-Day 841)
- Percentage of participants reporting any adverse events of special interest (AESIs) grade 3 or higher from first dose of GSK3228836 up to study end. From first dose of GSK3228836 (Treatment 1-Day 1) up to study end (Treatment 2-Day 841)
- Percentage of participants who achieve sustained virologic response (SVR) for 24 weeks after the planned end of active treatment in the absence of rescue medication, and difference between treatment arms (corresponding to GSK3228836 regimens). For up to 24 weeks after
External Link
https://clinicaltrials.gov/study/ NCT05276297
Order
2
Disease
Version
Phase
2