Hepatitis B
Conditions
Brief summary
Incidence of AEs, SAEs, withdrawals due to AEs, Incidence of clinically significant laboratory parameters (haematology, clinical chemistry, urinalysis), vital signs, cardiac parameters (electrocardiogram), and sensory nerve conduction, In Part 3 - Maximum reduction of serum HBsAg levels from baseline over 6 weeks (4 weeks on treatment and 2 weeks post-treatment), In Part 4 - Achieving complete response (undetectable serum HBV DNA and HBsAg for 6 consecutive months after the planned end of treatment of bepirovirsen)
Detailed description
In Part 3 - AUC(0-tau), Cmax, Tmax, and apparent terminal half-life (T1/2) will be calculated as data permits, In Part 3 - >=0.5x log IU/mL reduction of serum HBsAg levels from baseline anytime during the study (on-treatment and post-treatment), In Part 3 - Incidence of AEs, SAEs, withdrawals due to AEs and incidence of clinically significant laboratory parameters (haematology, clinical chemistry, urinalysis) and vital signs occurring in participants taking bepirovirsen monotherapy after completing GSK3965193/placebo monotherapy, In Part 4 - HBsAg loss (defined by two consecutive measurements of HBsAg below the limit of quantification) anytime during the study (on-treatment and post-treatment)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of AEs, SAEs, withdrawals due to AEs, Incidence of clinically significant laboratory parameters (haematology, clinical chemistry, urinalysis), vital signs, cardiac parameters (electrocardiogram), and sensory nerve conduction, In Part 3 - Maximum reduction of serum HBsAg levels from baseline over 6 weeks (4 weeks on treatment and 2 weeks post-treatment), In Part 4 - Achieving complete response (undetectable serum HBV DNA and HBsAg for 6 consecutive months after the planned end of treatment of bepirovirsen) | — |
Secondary
| Measure | Time frame |
|---|---|
| In Part 3 - AUC(0-tau), Cmax, Tmax, and apparent terminal half-life (T1/2) will be calculated as data permits, In Part 3 - >=0.5x log IU/mL reduction of serum HBsAg levels from baseline anytime during the study (on-treatment and post-treatment), In Part 3 - Incidence of AEs, SAEs, withdrawals due to AEs and incidence of clinically significant laboratory parameters (haematology, clinical chemistry, urinalysis) and vital signs occurring in participants taking bepirovirsen monotherapy after completing GSK3965193/placebo monotherapy, In Part 4 - HBsAg loss (defined by two consecutive measurements of HBsAg below the limit of quantification) anytime during the study (on-treatment and post-treatment) | — |
Countries
France, Italy