Chronic Hepatitis B Virus (HBV) Infection
Conditions
Brief summary
• Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) with HBsAg loss (< 0.05 IU/mL) at 24 weeks after discontinuation of all treatment • Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) at 24 weeks after discontinuation of all treatment • Proportion of participants with HBsAg loss (< 0.05 IU/mL) at 24 weeks post-end of treatment, • Proportion of participants achieving suppression of HBV DNA (< LLOQ [lower limit of quantitation]) with HBsAg loss (< 0.05 IU/mL) at the end of treatment • Proportion of participants with HBsAg loss (< 0.05 IU/mL) at the end of treatment • Mean change in serum HBsAg from baseline across timepoints in the study
Detailed description
1. Proportion of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) 2. Proportion of participants with serum HBsAg < 10 IU/mL at the end of treatment 3. Proportion of participants with serum HBsAg < 10 IU/mL at 24 weeks post-end of treatment 4. Serum HBsAg levels and change from baseline across timepoints in the study, 5. Serum HBsAg level at nadir during the study 6. Time to achieve nadir of serum HBsAg during the study 7. Time to achieve serum HBsAg loss (< 0.05 IU/mL) 8. Proportion of participants with HBsAg loss and anti-HBs seroconversion at end of treatment and at 24 weeks post-end of treatment
Interventions
Sponsors
Vir Biotechnology Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) with HBsAg loss (< 0.05 IU/mL) at 24 weeks after discontinuation of all treatment • Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) at 24 weeks after discontinuation of all treatment • Proportion of participants with HBsAg loss (< 0.05 IU/mL) at 24 weeks post-end of treatment, • Proportion of participants achieving suppression of HBV DNA (< LLOQ [lower limit of quantitation]) with HBsAg loss (< 0.05 IU/mL) at the end of treatment • Proportion of participants with HBsAg loss (< 0.05 IU/mL) at the end of treatment • Mean change in serum HBsAg from baseline across timepoints in the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) 2. Proportion of participants with serum HBsAg < 10 IU/mL at the end of treatment 3. Proportion of participants with serum HBsAg < 10 IU/mL at 24 weeks post-end of treatment 4. Serum HBsAg levels and change from baseline across timepoints in the study, 5. Serum HBsAg level at nadir during the study 6. Time to achieve nadir of serum HBsAg during the study 7. Time to achieve serum HBsAg loss (< 0.05 IU/mL) 8. Proportion of participants with HBsAg loss and anti-HBs seroconversion at end of treatment and at 24 weeks post-end of treatment | — |
Countries
France, Romania
Outcome results
None listed