Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04891770 | Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB) | PHASE2 | COMPLETED | 103 | — | — | Aug 14, 2021 | Jul 19, 2024 | Jul 24, 2025 | 26 | Australia, Denmark +6 |
Functional cure was defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) less than the lower limit of quantitation (LLOQ) at follow-up Week 24. LLOQ for HBV DNA CAP/CTM 2.0 is 20 IU/mL. LLOQ for HBV DNA Cobas 6800 is 10 IU/mL. The HBsAg loss was defined as HBsAg changing from positive at baseline to negative at any postbaseline visit. Percentages were rounded off.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: TAF + VIR-2218 + SLGN + Nivolumab | EXPERIMENTAL | Nucleos(t)ide(s) (NUC)-suppressed participants with chronic hepatitis B (CHB) will receive tenofovir alafenamide (TAF) 25 mg orally once daily (QD) for 36 weeks and VIR-2218 200 mg subcutaneously (SC) once every 4 weeks (Q4W) for 24 weeks. From Week 12 onwards, participants will receive selgantolimod (SLGN) 3 mg orally once a week (QW) for 24 weeks and nivolumab 0.3 mg/kg intravenously (IV) Q4W for up to 24 weeks (only up to protocol amendment 2, nivolumab was no longer administered post implementation of protocol amendment 2). Participants who are on TAF treatment will continue TAF treatment over the duration of study follow-up. Participants will be followed up for 48 weeks post treatment. |
| Cohort 2 Group A: VIR-2218 + SLGN + Nivolumab | EXPERIMENTAL | Viremic participants with CHB will receive VIR-2218, 200 mg SC Q4W for 24 weeks. From Week 12 onwards, participants will receive SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks (only up to protocol amendment 2, nivolumab was no longer administered post implementation of protocol amendment 2). Participants who meet the criteria to initiate NUC treatment will receive TAF 25, mg orally, QD during the study. Participants will be followed up for 48 weeks post treatment. |
| Cohort 2 Group B: SLGN + Nivolumab | EXPERIMENTAL | Viremic participants with CHB will receive SLGN 3 mg orally QW for 24 weeks and nivolumab 0.3 mg/kg IV Q4W for up to 24 weeks. . Viremic participants who meet the criteria to initiate NUC treatment will receive TAF 25 mg orally QD during the study. Participants will be followed up for 48 weeks post treatment. All treatments were administered up to protocol amendment 2 and after the implementation of protocol amendment 2, the treatments were discontinued for Cohort 2 Group B based on Sponsor decision. |
| Name | Type | Description |
|---|---|---|
| Tenofovir Alafenamide | DRUG | Administered as film-coated oral tablets |
| VIR-2218 | DRUG | Administered as a sub-cutaneous (SC) injection |
| Nivolumab | DRUG | Administered intravenously |
| Selgantolimod | DRUG | Administered as film-coated oral tablets |
Key Inclusion Criteria: * Willing and able to provide informed consent * Chronic HBV infection for at least 6 months * Willing to follow protocol-specified contraception requirement Key Exclusion Criteria: * Have extensive fibrosis or cirrhosis in the liver * Have or had liver cancer (hepatocellu...