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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06537414 | A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB) | PHASE2 | ACTIVE NOT_RECRUITING | 283 | — | — | Nov 11, 2024 | May 31, 2027 | Jul 28, 2025 | 81 | United States, Australia +17 |
The functional cure for Hepatitis B virus (HBV) is defined as sustained suppression (24 weeks or longer) of HBV deoxyribonucleic acid (DNA) \<lower limit of quantification (LLOQ) off all HBV treatment and HBsAg not detected with or without Hepatitis B Surface Antibody (HBsAb) after a finite duration of therapy. The number of participants achieving functional cure after discontinuation of all chronic HBV treatments (DAP/TOM, bepirovirsen, and NA treatment) will be reported.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm 1A: DAP/TOM + Bepirovirsen | EXPERIMENTAL | Participants with high Hepatitis B surface antigen (HBsAg) level will receive dose level 1 of DAP/TOM in Treatment Stage 1. After DAP/TOM Treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment. |
| Treatment Arm 1B: DAP/TOM + Bepirovirsen | EXPERIMENTAL | Participants with high HBsAg level will receive dose level 2 of DAP/TOM in Treatment Stage 1. After DAP/TOM treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment. |
| Treatment Arm 2A: DAP/TOM + Bepirovirsen | EXPERIMENTAL | Participants with low HBsAg level will receive dose level 1 of DAP/TOM in Treatment Stage 1. After DAP/TOM treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment. |
| Treatment Arm 2B: DAP/TOM + Bepirovirsen | EXPERIMENTAL | Participants with low HBsAg level will receive dose level 2 of DAP/TOM in Treatment Stage 1. After DAP/TOM treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment. |
| Treatment Arm 2C: Placebo + Bepirovirsen | EXPERIMENTAL | Participants with low HBsAg level will receive Placebo in Treatment Stage 1. After Placebo treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment. |
| Name | Type | Description |
|---|---|---|
| Daplusiran/Tomligisiran Dose Level 1 | DRUG | Daplusiran/Tomligisiran dose level 1 will be administered |
| Daplusiran/Tomligisiran Dose Level 2 | DRUG | Daplusiran/Tomligisiran dose level 2 will be administered |
| Bepirovirsen | DRUG | Bepirovirsen will be administered |
| Placebo | DRUG | Placebo will be administered |
Inclusion Criteria: * Age: At least 18 years of age at the time of signing the informed consent. * Documented chronic HBV infection \>=6 months prior to Screening AND currently receiving stable NA therapy defined as receiving an NA regimen form at least 6 months prior to Screening and with no plann...